Tag Archives: biosimilars

Unfettered ‘Access To Drug Innovation’ – An Oxymoron?

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The mass paranoia, as it were, over Covid pandemic has now started fading with drug regulators’ ‘emergency approval’ of several Covid -19 vaccines, and its free of cost access to all, generally in most countries. As the endgame of the pandemic, supposedly, depends on the speed of Covid-19 vaccination, the drug industry’s public reputation in the interim period, driven by its rapid response to the crisis, got an unsurprising boost (62%). This was captured by the Harris Poll, released on March 15, 2021.

Interestingly, soon after the high of 62% approval rating, the decline began. It came down to 60% in May and then 56% in June 2021—and now down three more percentage points, according to the Harris Polls that followed. No wonder, why the FiercePharma article of August 24, 2021, carried a caption: ’Pharma’s reputation drops again. Could it foreshadow a return to the bottom?’

Further, in the new normal, especially when customer expectations and requirements from drug companies have significantly changed, MNC Pharma industry still appears to be in the old normal mode in this space. It still, reportedly, ‘believes that the need for innovation must be balanced with the necessity for more accessible medicines, within a robust IP and regulatory environment,’ in India.

The hidden purpose of the same could possibly be, as several industry watchers believe – availing benefits of greater access to one kind innovation, making access to other kind of innovation more difficult. Consequently, two critical points are reemerging, even in the new normal, as follows:

  • Aren’t Indian IP and regulatory ecosystems still conducive enough for MNC pharma players’ access to drug innovation?
  • In the name of greater access to pharma product innovation, are they creating barriers to pharma process innovation, delaying market access to complex generics and Biosimilar drugs – besides systematically eroding consumer confidence on such products?

In this article, under the above backdrop, I shall try to explore why the epithet – ‘access to drug innovation’ is considered an oxymoron – with contemporary examples from around the word, including India.

Aren’t Indian IP and regulatory ecosystems conducive to drug innovation? 

This allegation doesn’t seem to hold much water, as several successful local initiatives in Covid-19 vaccine development will confirm the same. Besides, already marketed Covaxin, developed by Bharat Biotech in collaboration with the Indian Council of Medical Research (ICMR) and Zydus Cadila’s ZyCov-D, there are several others waiting in the wings. These include domestic drug makers like, Hyderabad based Biological-E, Bengaluru-based medical pharma startup’s – Mynvax, and Pune-based Gennova Biopharmaceutical’s m-RNA vaccine candidates. However, only critical difference is – Indian made Covid vaccines are more affordable and accessible to patients, as against those manufactured by MNCs, such as, Pfizer, Moderna and J&J.

If we look back to the old normal, one will also find similar instances of new drug discovery in India, which deliberated in my article of September 02, 2013. Let me give just a couple of examples below:

  • Ranbaxy developed and launched its first homegrown ‘New Drug’ for malaria - Synriam, on April 25, 2012
  • Zydus Cadila announced in June 2013 that the company is ready for launch in India its first New Chemical Entity (NCE) for the treatment of diabetic dyslipidemia –Lipaglyn.

Hence, meager wherewithal for R&D notwithstanding, as compared to the MNCs, Indian pharma players don’t seem to find the country’s IP and regulatory ecosystems not conducive to innovation of affordable new drugs with wider patient access.

Off-patent drugs also involve another type of major innovation:

Discovering an NCE is, unquestionably, a product of drug innovation. Similarly, developing a new – cost-effective, non-infringing manufacturing process to market off-patent drugs, like biosimilars, also involve another type of major innovation. Intriguingly, when the MNC pharma industry talks about ‘access to innovation’, the latter type of innovation isn’t publicly acknowledged and included in their drug innovation spectrum. This practice, reportedly, remains unchanged in their advocacy campaign, even in the new normal.

However, the fact is, the manufacturers of off-patent drugs, such as biosimilars, also need to follow a major innovative process, for which they require access to innovation. This was also captured in an editorial of the newsletter – Biosimilar Development. The deliberation addressed the question - Do biosimilars fit into the innovation paradigm? The editor began by articulating – hardly anyone publicly argues that the development of new manufacturing process of Biosimilar drugs is not an innovation. The industry can’t call them as a copy of an existing innovation, either.

This is also vindicated in the Amgen paper, published on February 11, 2018. It acknowledges, “Unlike small molecule generic drugs, biosimilars are not identical to the reference biologic or to other approved biosimilars of the same reference biologic, because they are developed using different cell lines and undergo different manufacturing and purification processes.” Moreover, biosimilars also carry a different International Nonproprietary Name (INN), because of their molecular differences from the reference drug. This has been specified in the nonproprietary naming Guidance document of the US-FDA of January 2017.

From this perspective, the next question that logically follows: Is process innovation as important as product innovation?

Is process innovation as critical a capability as product innovation?

This question was unambiguously answered by a pharma industry-centric Harvard Business Review(HBR) article – ‘The New Logic of High-Tech R&D’, published in its September–October 1995, issue. The paper emphasized, for the commercial success of a product ‘manufacturing-process innovation is becoming an increasingly critical capability for product innovation.’

When to meet patient-needs ‘access to innovation’ an oxymoron: 

‘Access to innovation’ is an interesting epithet that is often used by many drug companies for meeting unmet needs of patients. However, the same is also often used to create barriers to meeting unmet needs of more patients with cheaper biologic drugs, like Biosimilars, immediately after their basic patent expiry. This is mostly practiced by creating a patent thicket. Hence, drug companies’ advocacy for greater access to innovation is an oxymoron to many.

The same was echoed in another article – ‘How originator companies delay generic medicines,’ published by GaBI. It wrote, such practices delay generic entry and lead to healthcare systems and consumers paying more than they would otherwise have done for medicines. These include the following:

  • Strategic patenting
  • Patent litigation
  • Patent settlements
  • Interventions before national regulatory authorities
  • Lifecycle strategies for follow-on products.

A very recent piece on the subject, published by Fierce Pharma on August 31, 2021, vindicates that the patent life extension through the patent thicket is happening on the ground – denying patients access to cheaper equivalent, especially of off-patent biologic drugs within a reasonable time period. It highlighted:

  • The exclusivity of AbbVie’s Humira, which hit the market in 2002 and generated nearly $20 billion in sales last year was extended by 130 patents.
  • The same company has applied for 165 patents for its another blockbuster Imbruvica. Launched in 2013, Imbruvica has already generated sales of $5.3 billion for AbbVie.

No wonder, why in February 2021, during a Senate Finance Committee hearing, Sen. John Cornyn blasted the company saying:

“I support drug companies recovering a profit based on their research and development of innovative drugs,” Cornyn said. “But at some point, that patent has to end, that the exclusivity has to end, to be able to get it at a much cheaper cost.”

More reports are also available on attempts to erode consumer confidence in Biosimilar drugs, as compared to the originals.

Work for innovation sans eroding consumer confidence in Biosimilars: 

Making affordable new drugs and vaccines available to patients with ‘access to innovation’, deserves inspiration from all concerned. Curiously, even in the new normal, some big companies continue trying to erode consumer confidence in off-patent drugs, especially Biosimilars and complex generics.

For example, an article on Biosimilars moving to the center stage, published in the Pharmaceutical Executive on August 12, 2021, quoted an interesting development in this space. The article highlighted that US legislators are now ‘eyeing measures to deter innovator promotional messages that disparage follow-on competitors.’ This initiative was spurred by US-FDA criticism of an Amgen promotional communication for undermining consumer confidence in Biosimilars to its Neulasta (pegfilgrastim) injection.

On July 14, 2021, US-FDA’s Office of Prescription Drug Promotion (OPDP) sent a letter to Amgen carrying a caption ‘FDA notifies Amgen of misbranding of its biological product, Neulasta, due to false or  misleading promotional communication about its product’s benefit.

The letter, as reported in the above article, criticized the company for making a false claim of greater adverse events with the injection system used by Biosimilars compared to the Amgen product. OPDP advised Amgen and other firms to “carefully evaluate the information presented in promotional materials for reference products, or Biosimilar products” to ensure correct product identification and avoid consumer confusion.

Conclusion:

When the point is, creating a conducive ecosystem to promote access to innovation, it should be patient-centric – always, and, more so in the new normal, considering changing needs and expectations of health care customers.

The innovation of usually pricey new molecular entities, no doubt, meets unmet needs of those who can afford these. Whereas, manufacturing process innovation expands access to the same molecule, particularly when they go off-patent, by making them affordable to a vast majority of the population.

But powerful industry lobby groups continue pressing harder for unfettered ‘access to innovation’ with greater relaxation of the IP and regulatory framework of countries, like India. The situation prompts striking a right balance between encouraging more profit by helping to extend patent exclusivity and encouraging greater access to off-patent cheaper Biosimilars as soon as the basic patent expires.

The bottom-line is, both need to be actively encouraged, even if it requires new laws to discourage practices like, creating patent thickets or undermining the use of generics or Biosimilars, and the likes. The good news is lawmakers have started deliberating on this issue – along with increasing public awareness, which gets reflected in the pharma industry’s current reputation ratings.

Left unresolved soon, such piggyback ride on ‘access to drug innovation’ bandwagon to serve self-serving interests, would continue denying speedy entry of cheaper Biosimilars. From this perspective, it isn’t difficult to fathom, why unfettered access to drug innovation is considered an oxymoron, by many.

By: Tapan J. Ray  

Disclaimer: The views/opinions expressed in this article are entirely my own, written in my individual and personal capacity. I do not represent any other person or organization for this opinion.

Biosimilar Drugs: Why Prescriptions Aren’t Still Enough?

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On September 3, 2015, in a Press Release, Novartis announced, “Zarxio(TM) (filgrastim-sndz) is now available in the United States. Zarxio is the first biosimilar approved by the US Food and Drug Administration (FDA) and the first to launch in the US.” Zarxio is being marketed by the generic drug unit of Novartis – Sandoz.

The company highlighted: “With the launch of Zarxio, we look forward to increasing patient, prescriber and payor access to filgrastim in the US by offering a high-quality, more affordable version of this important oncology medicine.” This statement may be interpreted as an acknowledged of a research based global pharma major that high-priced biologics create a notable access barrier to a large number of patients, even in a rich country such as the United States. It also underscores the increasing prescription opportunities for cheaper biosimilar drugs.

Zarxio will initially be available with a 15 percent discount. This needs to be viewed against usual price drop of around 20-30 percent for biosimilar drugs in Europe, as compared to the original molecules. It is expected that price differences between biosimilar drugs and the original ones, would vary widely from as low as 10 percent to a hefty 60 percent, in the global markets.

Prior to Novartis’s Press Release, USFDA announced Zarxio’s approval in a separate ‘FDA News Release on March 6, 2015, indicating that it can be prescribed by a health care professional for:

  • patients with cancer receiving myelosuppressive chemotherapy
  • patients with acute myeloid leukemia receiving induction or consolidation chemotherapy
  • patients with cancer undergoing bone marrow transplantation
  • patients undergoing autologous peripheral blood progenitor cell collection and therapy a
  • patients with severe chronic neutropenia.

Though such types of drugs are available in the important markets such as, Europe, Australia and India, the launch of Zarxio heralds the dawn of a new era of biosimilar drugs in the United States – the numero uno of the global pharma market.

Incidentally, USFDA’s approval of biosimilar drugs is an outcome of a relatively recent healthcare reform in the United States, when President Obama signed into law the ‘Affordable Care Act’ on March 23, 2010.

The key benefit:

In its above ‘Press Release’, Novartis captured well the key benefits of biosimilar drugs , as follows:

“While biologics have had a significant impact on how diseases are treated, their cost and co-pays are difficult for many patients and the healthcare budget in general.  Biosimilars can help to fill an unmet need by providing expanded options, greater affordability and increased patient access to life-saving therapies.”

Major growth drivers:

According to July 2015 report of ‘MarketsandMarkets (M&M)’ the global biosimilars market is expected to grow to US$6.22 Billion by 2020 from US$2.29 Billion in 2015, growing at a CAGR of 22.1 percent from 2015 to 2020.

The major growth drivers of the global biosimilars market are expected to be:

  • Growing pressure to curtail healthcare expenditure
  • Growing demand for biosimilar drugs due to their cost-effectiveness
  • Rising incidences of various life-threatening diseases
  • Increasing number of off-patented biologics
  • Positive outcome in the ongoing clinical trials
  • Rising demand for biosimilars in different therapeutic applications such as rheumatoid arthritis and blood disorders.

European Union (EU) had a head start of 5 to 7 years to put its regulatory pathway for biosimilar drug development and approval process. Thus, at present practically most the entire value sales of biosimilar drugs take place in the EU.

As, cheaper biosimilars would continue to hit the US market, insurance companies are expected to encourage the use of such drugs instead of highly expensive original ones.

According to Express Scripts report released in December 2014, the US healthcare system could clock savings in drug costs around US$250 billion in the first decade of availability of biosimilars drugs and the approval of Zarxio would help patients saving more than US$5 billion in the the world’s largest market for biologics.

By 2020, several blockbuster biological products with global sales of more than US $67 billion would go or are going off-patent, creating great opportunities for biosimilar drugs the world over. Some of these drugs are Avastin (Roche), Humira (AbbVie), Synagis (AstraZeneca), Aranesp (Amgen) and Enbrel (Amgen, Pfizer).

However, the crux of its success, to a great extent, would lie on physicians’ confidence to prescribe large molecule biosimilar drugs, as these are new and not exact replicas of the original biologic molecules, unlike the small molecule generic drugs.

Possible growth barriers:

The success requirements of large molecule biosimilar drugs would not mimic the same for small molecule generics, anywhere in the world.

In my view, there are two types of critical barriers to success with biosimilars, both tangible and intangible in nature.

The same M&M report lists the following factors as possible tangible barriers to fast growth of biosimilar drugs:

  • High manufacturing complexities and costs
  • Stringent regulatory requirements in countries
  • Innovative strategies by biologic drug manufacturers to restrict the entry of new players

I would very briefly touch upon each one of these, hereunder:

I. High manufacturing complexities and costs:

This is primarily because, the therapeutic characteristics of biosimilar drugs are significantly influenced by their manufacturing methods. For example, it is quite possible that based on the manufacturing system that is adopted, the same starter ingredients may give substantially different results.

II. Stringent regulatory requirements:

Among many other stringent regulatory requirements, I would highlight in this article just the following two:

A. The labeling:

It is noteworthy that USFDA has named Zarxio with the placeholder nonproprietary name “filgrastim-sndz” and not as ‘filgrastim’, the nonproprietary name for Amgen’s, Neupogen, for which Zarxio has been approved as a biosimilar.

To quickly recapitulate its background, in July 2014, the World Health Organization (WHO), which oversees the system of International Nonproprietary Names (INN), recommended that biosimilar drugs would receive the same nonproprietary name, but with a four-letter code at the end.

This is primarily because, innovator biologic drug companies and also some doctors’ groups argue that molecular structures of biosimilar drugs are similar, but not exact replicas of the original ones. Hence, there is a need to differentiate them, while assigning INN.

They reiterate that giving biosimilars the same INN as the original biologic molecule may cause confusion among both the doctors and the patients. It could also make the tracking of adverse reactions, as and when these will be reported, more challenging.

Consequently, it has now been accepted by the regulators that biosimilars would receive the same nonproprietary name but with a four-letter code at the end to differentiate such drugs from the original biologics.

B. Interchangeability:

The above labelling issue, in turn, creates a barrier to possible interchangeability or automatic substitution of expensive original biologics with much cheaper equivalent of biosimilar drugs. I reckon, this could pose a critical obstacle in the initial take-off of the later.

According to a July 4, 2015 article, titled “Fate of cost-saving biosimilar drugs may hinge on naming policy”, published in ‘Modern Healthcare’, the USFDA has the following two pathways for licensing of biosimilar drugs:

  • For being designated as “similar” in efficacy and safety to an original biologic.
  • For being approved as being “interchangeable,” which requires a much higher review standard and could take years and millions of dollars to obtain the needed clinical trial data.

According to this article, none of the biosimilar products currently under USFDA review are in the interchangeable pathway.

III.  Innovative strategies to restrict entry of new players:

All the above innovative strategic moves and arguments, where biologic drug manufacturers are allegedly involved, may seriously restrict not just the entry of newer biosimilars, but also their faster prescription throughput.

Safety concern (immunogenicity):

Additionally, a critical safety concern on biosimilar drugs is being raised by the manufacturers of original biologics. This concern involves immunogenicity, which means the way a biosimilar drug provokes an immune response in the body. Original biologic drug manufacturers contend, since biosimilar molecules are not exactly the same as originals and their long term safety, related to immunogenicity, has not been tested, these drugs cannot be construed as having the same safety profile as the innovators’ biologics.

Besides, ‘Free-Trade-Agreements (FTAs)’ are also likely to be cleverly used by the original biologic drug manufacturers through their respective Governments, to the extent possible, for safeguarding the beachhead from the marketing onslaught of biosimilar drugs.

A perception barrier too:

Here comes an important perception-based intangible barrier to desirable prescription growth for biosimilar drugs.

Probably gauging it, post Zarxio launch, none other than the CEO of Novartis – Joe Jimenez, reportedly said: “He’s not expecting too much of a splash before 2020.”

This is understandable, as the doctors’ favorable disposition towards biosimilar drugs would be a crucial factor for prescription growth of these medicines.

A recent doctor community survey from QuantiaMD primarily captures the doctors’ thoughts and feelings on biosimilar drugs. This study was done with 300 specialists and primary care physicians.

Some of the notable findings of the report are as follows:

  • While 78 percent of the doctors polled said they were familiar with the term “biosimilar,” only 38 percent could name a biosimilar that’s under consideration for USFDA approval and would be relevant to their patient population.
  • Only 33 percent could name a biosimilar at all.

Researchers then narrowed down the original 300 physicians polled into a group of 120 “prescribing specialists.” This group of 120 doctors are currently prescribing biologics and most likely to prescribe biosimilar drugs in the years ahead. The study reported:

  • Only 17 percent of that segment said they are “very likely” to prescribe biosimilars.
  • And 70 percent said they either aren’t sure or are “somewhat likely’” to prescribe a biosimilar.
  • Only 12 percent of prescribing specialists are “very confident” that biosimilars are as safe as the original biologic version of the drug.

That said, 12-year ‘Data Exclusivity’ period for biologics in the United States, is one additional barrier to early introduction of cheaper biosimilar drugs, as considered by many.

On this issue GPhA – the generic drug makers’ group in America reportedly issued a statement, criticizing a paper of Biotechnology Industry Organization (BIO), saying:

“Market exclusivity acts as an absolute shield to their weak patents. Thus, from a practical perspective, extending market exclusivity beyond the Hatch-Waxman period would block the introduction of generic competition for almost 20 years, derailing any potential cost savings by Americans.”

The challenges ahead:

Considering all these together, the challenges ahead for quick acceptance of biosimilar drugs are indeed mind-boggling. The situation necessitates enough innovative and painstaking work by all concerned to gain the doctors’ confidence on biosimilar medicines. It goes without saying that success in generation of enough prescriptions for these drugs is the fundamental requirement to benefit the patients, which, in turn, would lead to significant savings in health care cost, as estimated above.

As more innovator companies start joining the biosimilar bandwagon, the physicians’ perception on these medicines, hopefully, would change sooner.

The status in India:

Although it appears strange, but a fact nonetheless. Biosimilar drugs approved in India till August 2012, followed the requirements of the regulators as provided mostly in the Drugs and Cosmetics Act for small molecule drugs, which are incidentally quite a different kettle of fish.

According to GaBI-online, the first locally produced biosimilar drug was approved and marketed in the year 2000. India announced implementation of its ‘Guidelines’ for ‘Similar Biologics’ much later, on September 15, 2012.

Indian ‘Guidelines’ for ‘Similar Biologics’ were jointly developed by the Department of Biotechnology (DoB) and the Central Drugs Standard Control Organization (CDSCO). The ‘Guidelines’ outline requirements for pre-clinical evaluation of biological products, claiming ‘similar to already approved biologics’. Thus, Indian regulators will partly rely on data from the already approved products to ensure safety, purity, potency and effectiveness of these drugs.

A wide variety:

A wide variety of biosimilar drugs have been approved and marketed in India, since then.

According to International Journal of Applied Basic Medical Research (2014 Jul-Dec; 4.2: 63–66), biosimilars in India consist primarily of vaccine, monoclonal antibodies, recombinant proteins and diagnostics, insulin, erythropoietin, hepatitis B vaccine, granulocyte colony stimulating factor, streptokinase, interferon alpha-2B and epidermal growth factor receptor.

The above article states that there are about 100 biopharmaceutical companies actively involved in research and development, manufacturing and marketing of biosimilar therapeutic products in India. Only 14 therapeutic drugs (similar biologics) were available in 50 brands in 2005. This number had grown to 20 therapeutic drugs in 250 brands in 2011.

The status of similar biologics approved and marketed in India is elaborated in this Table 1.

Some of the key Indian players of biosimilar drugs are Dr. Reddy’s Laboratory (DRL), Lupin, Zydus Cadila, Serum Institute of India, Biocon, Reliance Life Sciences, Wockhardt, Zenotech Laboratories and Intas.

I wrote on a related subject in this blog dated December 15, 2014 titled, “A Great News! But…Would This ‘Golden Goose’ Lay Golden Eggs?”

Conclusion:

Opportunities for biosimilar drugs are expected to expand significantly all over the world, basically driven by the need for affordable biologics and healthcare cost containment pressure in many countries.

As I had articulated before, unlike small molecule generics, unlocking the true potential of large molecule biosimilar drugs in a sustainable way would demand innovative, clear, razor sharp and highly focused business strategies across the value chain.

For faster growth in prescriptions, biosimilars would call for a hybrid marketing model of small molecule (branded) generics and large molecule original biologics. Ability to craft impactful value proposition and ensuring its effective delivery for each stakeholder, smart and innovative use of interactive and participative digital tools both for doctors’ and patients’ engagement, of course sans complexities, would decide the ultimate commercial fate for each of these types of products.

To effectively reap rich harvest from the new space thus being created, the challenges are also too many. The concerns expressed on biosimilars may also be genuine, but the regulators should take care of those before granting marketing approval to benefit the patients, in a meaningful way.

Overall key drivers and barriers for success with biosimilar drugs would remain almost the same, both for global and local players. However, carving out and thereafter expanding share in this market, sizably, won’t be a piece of cake for any company, understandably.

Quite naturally, the innovator companies for biologics would go all out to retain their turf as much as possible, despite the entry of cheaper biosimilars. This is expected to continue by reinforcing the belief of the physicians and the patients that biosimilars are not quite the same as the original biologic molecules.

Effective proactive measures need to be initiated, soon, by the regulators and all other stakeholders to spread the right message, protecting the patients’ interest. Otherwise, apprehension of the doctors on biosimilars in general, regarding safety, efficacy, substitution and interchangeability may persist for some time to come, negatively impacting faster and desirable prescription growth of these drugs all over the world, including India.

By: Tapan J. Ray

Disclaimer: The views/opinions expressed in this article are entirely my own, written in my individual and personal capacity. I do not represent any other person or organization for this opinion.

 

Moving Up The Generic Pharma Value Chain

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June 2014 underscores a significant development for the generic drug exporters of India. Much-delayed and highly expected launch of generic Diovan (Valsartan) is now on its way, as Ranbaxy has reportedly received US-FDA approval to launch the first generic version of this blood pressure drug in the United States.

As deliberated in my earlier blog titled “Big Pharma’s Windfall Gain From Indian Pharma’s Loss, Costs American Patients Dear”, delay in launch of the generic equivalent of Diovan caused a windfall gain for Novartis from US$ 1.7 billion US sales of this drug last year, instead of usual declining turnover of an innovative molecule post patent expiry.

The generic version of Diovan (Valsartan) is estimated to contribute around US$ 200 million to Ranbaxy’s sales and US$ 100 million to its profit after tax, during the exclusive sale period. Against these numbers, delay in the launch of generic Diovan has reportedly cost payers and consumers in America around US$ 900 million in the first 18 months.

Since four Ranbaxy manufacturing facilities in India are now facing US-FDA ‘import bans’ due to violations of ‘Good Manufacturing Practices’ of the American regulator, its Ohm Laboratories unit located in New Jersey has been allowed to make generic Valsartan for the US.

Go for gold: 

Hopefully, Ranbaxy would soon get similar approvals from the US drug regulator for its ‘first to launch’ generic versions of Nexium (AstraZeneca) and Valcyte (Roche), as well.

It is worth mentioning that around 90 percent price erosion would take place with intense competition, as soon the period of exclusivity for such ‘first to launch’ generics gets over.

Nonetheless, this is indeed a very interesting development, when the global generic pharmaceutical segment is reportedly showing signals of a tough chase for overtaking the branded pharmaceuticals sector in terms of sales turnover too.

India has a huge a stake in this ball game, as it supplies around 30 to 40 percent of the world’s generic medicines and is well poised to improve its pharma exports from around US$ 15 billion per year to US$ 25 billion by 2016. Since 2012, this objective has remained an integral part of the country’s global initiative to position India as the “pharmacy to the world.”

However, considering the recent hiccups of some Indian pharma majors in meeting with the quality requirements of the US-FDA, though this target appears to be a challenging one for now, the domestic pharma players should continue to make all out efforts to go for the gold by moving up the generic pharmaceutical value chain. In this context, it is worth noting that penetration of the generic drugs in the US is expected to increase from the current 83 percent to 86-87 percent very shortly, as the ‘Obamacare’ takes off with full steam.

Moving up the value chain:

In the largest pharma market of the world – the United States, global generic companies are increasingly facing cutthroat price competition with commensurate price erosion, registering mixed figures of growth. Even in a situation like this, some companies are being immensely benefited from moving up the value chain with differentiated generic product launches that offer relatively high margin, such as, specialty dermatologicals, complex injectibles, other products with differentiated drug delivery systems and above all biosimilars.

As a consequence of which, some Indian generic companies have already started focusing on the development of value added, difficult to manufacture and technology intensive generic product portfolios, in various therapy areas. Just to cite an example, Dr. Reddy’s Laboratories (DRL) is now reportedly set to take its complex generic drug Fondaparinux sodium injection to Canada and two other emerging markets.

Thus, those Indian pharma companies, which would be able to develop a robust product portfolio of complex generics and other differentiated formulations for the global market, would be much better placed in positioning themselves significantly ahead of the rest, both in terms of top and the bottom lines.

One such key opportunity area is the development of a portfolio of biosimilar drugs – the large molecule proteins.

Global interest in biosimilars:

According to the June 2014 report of GlobalData, a leading global research and consulting firm, the biosimilars industry is already highly lucrative. More than 100 deals involving companies focused on the development of biosimilars have been completed over the past 7 years, with a total value in excess of US$10.7 billion.

GlobalData further states, there are a number of factors driving the initiative toward global adoption of biosimilars, from austerity measures and slow economic growth in the US, to an aging population and increasing demand for healthcare in countries, such as Japan.

The costs of biosimilars are expected to be, at least, 20 to 30 percent lower than the branded biologic therapies. This still remains a significant reduction, as many biologics command hundreds of thousands of dollars for 1 year’s treatment.

According to another media report, biosimilars are set to replace around 70 percent of global chemical drugs over the next couple of decades on account of ‘safety parameters and a huge portion of biologic products going off patent’.

Biosimilar would improve patient access:

Although at present over 150 different biologic medicines are available globally, just around 11 countries have access to low cost biosimilar drugs, India being one of them. Supporters of biosimilar medicines are indeed swelling as the time passes by.

It has been widely reported that the cost of treatment with innovative and patented biologic drugs can vary from US$ 100,000 to US$ 300,000 a year. A 2010 review on biosimilar drugs published by the Duke University highlights that biosimilar equivalents of novel biologics would improve access to such drugs significantly, for the patients across the globe.

Regulatory hurdles easing off:

In the developed world, European Union (EU) had taken a lead towards this direction by putting a robust system in place, way back in 2003. In the US, along with the recent healthcare reform process of the Obama administration, the US-FDA has already charted the regulatory pathway for biosimilar drugs, though more clarifications are still required.

Not so long ago, the EU had approved Sandoz’s (Novartis) Filgrastim (Neupogen brand of Amgen), which is prescribed for the treatment of Neutropenia. With Filgrastim, Sandoz will now have at least 3 biosimilar products in its portfolio.

Key global players:

At present, the key global players are Sandoz (Novartis), Teva, BioPartners, BioGenerix (Ratiopharm) and Bioceuticals (Stada). With the entry of pharmaceutical majors like, Pfizer, Sanofi, Merck, Boehringer Ingelheim and Eli Lilly, the global biosimilar market is expected to be heated up and grow at a much faster pace than ever before. Removal of regulatory hurdles for the marketing approval of such drugs in the US would be the key growth driver.

Globally, the scenario for biosimilar drugs started warming up when Merck announced that the company expects to have at least 5 biosimilars in the late stage development by 2012.

Most recent global development:

A key global development in the biosimilar space has taken place, just this month, in June 2014, when Eli Lilly has reportedly won the recommendation of European Medicines Agency’s Committee for Medicinal Products for launch of a biosimilar version (Abasria insulin) of Sanofi’s Lantus insulin. This launch would pave the way for the first biosimilar version of Sanofi’s top-selling drug clocking a turnover of US$7.8 billion in 2013. Eli Lilly developed Abasria with Boehringer Ingelheim of Germany.

In May 2014, Lantus would lose patent protection in Europe. However, biosimilar competition of Lantus in the US could get delayed despite its patent expiry in February, as Sanofi reportedly announced its intention of suing Eli Lilly on this score.

Global Market Potential:

According to a 2011 study, conducted by Global Industry Analysts Inc., worldwide market for biosimilar drugs is estimated to reach US$ 4.8 billion by the year 2015, the key growth drivers being as follows:

  • Patent expiries of blockbuster biologic drugs
  • Cost containment measures of various governments
  • Aging population
  • Supporting legislation in increasing number of countries
  • Recent establishment of regulatory pathways for biosimilars in the US

IMS Health indicates that the US will be the cornerstone of the global biosimilars market, powering a sector worth between US$ 11 billion and US$ 25 billion in 2020, representing a 4 percent and 10 percent share, respectively, of the total biologics market.

The overall penetration of biosimilars within the off-patent biological market is estimated to reach up to 50 percent by 2020.

Challenges for India:

Unlike commonly used ‘small molecule’ chemical drugs, ‘large molecule’ biologics are developed from living cells using very complex processes. It is virtually impossible to replicate these protein substances, unlike the ‘small molecule’ drugs. One can at best develop a biologically similar molecule with the application of high degree of biotechnological expertise.

According to IMS Health, the following would be the key areas of challenge:

High development costs:

Developing a biosimilar is not a simple process but one that requires significant investment, technical capability and clinical trial expertise. Average cost estimates range from US$ 20-100 million against much lesser cost of developing traditional generics, which are typically around US$ 1-4 million.

Fledgling regulatory framework:

In most markets apart from Europe, but including the United States, the regulatory framework for biosimilars is generally still very new compared to the well-established approval process for NCEs and small-molecule generics.

Intricate manufacturing issues:

The development of biosimilars involves sophisticated technologies and processes, raising the risk of the investment.

Overcoming ‘Branded Mentality’:

Winning the trust of stakeholders would call for honed skills, adequate resources and overcoming the branded mentality, which is especially high for biologics. Thus, initiatives to allay safety concerns among physicians and patients will be particularly important, supported by sales teams with deeper medical and technical knowledge. This will mean significant investment in sales and marketing too.

Indian business potential:

The biosimilar drugs market in India is expected to reach US$ 2 billion in 2014 (Source: Evalueserve, April 2010).

Recombinant vaccines, erythropoietin, recombinant insulin, monoclonal antibody, interferon alpha, granulocyte cell stimulating factor like products are now being manufactured by a number of domestic biotech companies, such as, Dr. Reddy’s Laboratories, Lupin, Biocon, Panacea Biotech, Wockhardt, Glenmark, Emcure, Bharat Biotech, Serum Institute, Hetero, Intas and Reliance Life Sciences.

The ultimate objective of all these Indian companies is to get regulatory approval of their respective biosimilar products in the US and the EU either on their own or through collaborative initiatives.

Domestic players on the go:

Dr.Reddy’s Laboratories (DRL) in India has already developed Biosimilar version of Rituxan (Rituximab) of Roche used in the treatment of Non-Hodgkin’s lymphoma.  DRL has also developed Filgastrim of Amgen, which enhances production of white blood cell by the body and markets the product as Grafeel in India. DRL has launched the first generic Darbepoetin Alfa in the world for treating nephrology and oncology indications and Peg-grafeel, an affordable form of Pegfilgrastim, which is used to stimulate the bone marrow to fight infection in patients undergoing chemotherapy. The company reportedly sold 1.4 million units of its four biosimilars, which have treated almost 97,000 patients across 12 countries. Besides, in June 2012, DRL and Merck Serono, of Germany, announced a partnership deal to co-develop a portfolio of biosimilar compounds in oncology, primarily focused on monoclonal antibodies (MAbs). The partnership covers co-development, manufacturing and commercialization of the compounds around the globe, with some specific country exceptions.

Another Indian pharmaceutical major Cipla, has reportedly invested Rs 300 Crore in 2010 to acquire stakes of MabPharm in India and BioMab in China and announced in June 19, 2014 collaboration with Hetero Drugs to launch a biosimilar drug with Actroise brand name for the treatment of anemia caused due to chronic kidney disease. Actorise is a biosimilar of ‘Darbepoetin alfa’, which is marketed by US-based Amgen under the brand Aranesp.

In 2011, Lupin reportedly signed a deal with a private specialty life science company NeuClone Pty Ltd of Sydney, Australia for their cell-line technology. Lupin reportedly would use this technology for developing biosimilar drugs in the field of oncology. Again, in April 2014, Lupin entered into a joint venture pact with Japanese company Yoshindo Inc. to form a new entity that will be responsible both for development of biosimilars and obtaining marketing access for products in the Japanese market.

In November 2013, The Drug Controller General of India (DCGI) approved a biosimilar version of Roche’s Herceptin developed jointly by Biocon and Mylan.

In June 2014, Ipca Laboratories and Oncobiologics, Inc. of USA reportedly announced the creation of an alliance for the development, manufacture and commercialization of biosimilar monoclonal antibody products.

Many more such initiatives reportedly are in the offing.

Oncology becoming biosimilar development hot spot:

Many domestic Indian pharmaceutical companies are targeting Oncology disease area for developing biosimilar drugs, which is estimated to be the largest segment globally with a value turnover of around US$ 60 billion growing over 17 percent.

As per recent reports, about 8 million deaths take place all over the world per year due to cancer.

Indian Government support:

In India, the government seems to have recognized that research on biotechnology has a vast commercial potential for products in human health, including biosimilars, diagnostics and immune-biological, among many others.

To give a fillip to the Biotech Industry in India the National Biotechnology Board was set up by the Government under the Ministry of Science and Technology way back in 1982. The Department of Biotechnology (DBT) came into existence in 1986. The DBT currently spends around US$ 300 million annually to develop biotech resources in the country and has been reportedly making reasonably good progress.

The DBT together with the Drug Controller General of India (DCGI) has now prepared and put in place ‘Regulatory Guidelines for Biosimilar Drugs’ in conformance with the international quality and patient safety standards. This is a big step forward for India in the arena of biosimilar drugs.

In June 2014, under the advanced technology scheme of Biotechnology Industry Partnership Program (BIPP), the DBT has reportedly invited fresh proposals from biotech companies for providing support on a cost sharing basis targeted at development of novel and high risk futuristic technologies mainly for viability gap funding and enhancing existing R&D capacities of start-ups and SMEs in key areas of national importance and public good.

However, the stakeholders expect much more from the government in this area, which the new Indian government would hopefully address with a sense of urgency.

Conclusion: 

According to IMS Health, biosimilar market could well be the fastest-growing biologics segment in the next few years, opening up oncology and autoimmune disease areas to this category of drugs for the first time ever. Moreover, a number of top-selling biologic brands would go off patent over the next five years, offering possibilities of reaping rich harvest for the biosimilars players of the country. Critical therapy areas such as cancer, diabetes and rheumatoid arthritis are expected to spearhead the new wave of biosimilars.

While moving up the generic pharma value chain, Indian pharma players desiring to encash on the emerging global biosimilars opportunities would require to do a thorough analysis, well in advance, to understand properly the key success factors, core value propositions, financial upsides and risks attached to investments in this area.

Indian companies would also need to decide whether moving ahead in this space would be through collaborations and alliances or flying solo would be the right answer for them. Thereafter would come the critical market access strategy – one of the toughest mind games in the long-haul pharma marketing warfare.

By: Tapan J. Ray

Disclaimer: The views/opinions expressed in this article are entirely my own, written in my individual and personal capacity. I do not represent any other person or organization for this opinion.

 

Biologic Medicine: Ushers in a different ‘Mega Race’ for inorganic growth

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During the last several years the success of biologics compared to conventional small-molecule drugs to meet the unmet needs of patients, is gradually but surely changing the area of focus of pharmaceutical R&D altogether, making the biotech companies interesting targets for M&A. Over a period of so many years, the small-molecule blockbuster drugs business model made pharmaceuticals a high-margin industry. However, it now appears that the low hanging fruits to make blockbuster drugs have mostly been plucked.

These low hanging fruits involved therapy areas like, anti-ulcerants, anti-lipids, anti-diabetics, cardiovascular, anti-psychotic etc. and their many variants, which were relatively easy R&D targets to manage chronic ailments. Hereafter, the chances of successfully developing drugs for cure of these chronic ailments, with value addition, would indeed be a very tough call.

Deploying expensive resources towards finding a cure for so called ‘chronic diseases’ may also not promise a strong commercial incentive, as the treatment for ulcer, lipid disorders, diabetics, hypertension etc. are currently continues lifelong for a patient and a cure will limit the treatment to a short to medium term period.

Greater promise in biologics:

On the other hand, the bottom-line impact of a successful R&D outcome with safer and effective drugs to treat intractable ailments like,various types of cancer and blood disorders, auto-immune and Central Nervous System (CNS) related diseases, neurological disorders such as Parkinson’s, Myasthenia gravis, Multiple Sclerosis, Alzheimer’s diseases etc., will be huge. It is believed that well targeted drugs of biologic origin could well be successful treatment for such intractable diseases.

The golden opportunity of meeting the unmet needs of the patients with effective biologics, especially in high-growth therapeutics, as mentioned above, has given the M&A activities in the pharma-biotech space an unprecedented thrust.

Biologic versus conventional drugs:

Biologics Conventional and NME drugs
Large molecules (>5000 molecular weight) Small molecules (~500 molecular weight)
Bio-technologically produced or isolated from living sources Chemically synthesized
Complex structure/mixtures (tertiary structure, glycosylated) Simple well-defined structure
High target specificity Less target specificity
Generally parenteral administration (e.g., intravenous) Oral administration possible (pills)

(Source: MoneyTreeTM Report. PWC, 2009)

According to IMS, Biologics contribute around 17% of global pharmaceutical sales and generated a revenue of US$120 billion MAT March 2009. As we see today, gradually more and more global pharmaceutical companies, who used to spend around 15% to 20% of their annual sales in R&D, are channelizing a large part of the same to effectively compete in a fast evolving market of biologics through mainly M&A route. This is also driven by their strategic intent to make good the loss in income from the blockbuster drugs going off patent and at the same time fast dwindling R&D pipeline.

A shift from small molecule based blockbuster model to a biologics-based blockbuster one:

Frost & Sullivan forecasts a shift from small molecules-based blockbuster model to a biologics-based blockbuster one for the global pharmaceutical majors, just as biologics like Enbrel ,Remicade, Avastin, Rituxan and Humira, as mentioned below, have already proved to be money spinners.

The top 10 global brands in 2009:

Rank Product Chemical/Biologic Global Sales US$ Mn
1 Lipitior Chemical 12,511
2 Plavix Chemical 9,492
3. Seretide/Advair Chemical 7,791
4. Enbrel Biologic 6,295
5. Diovan Chemical 6,013
6. Remicade Biologic 5,924
7. Avastin Biologic 5,744
8. Rituxan Biologic 5,620
9. Humira Biologic 5,559
10. Seroquel Chemical 5,121

(Source: EvaluatePharma)

Faster growth of biologics attracting attention of large pharma players:

Currently, faster growth of biologics as compared to conventional new chemical entities is driven by novel technologies and highly targeted approach, the final outcome of which is being more widely accepted by both physicians and patients. The large global pharmaceutical companies are realizing it pretty fast. The type and quality of their recent acquisitions, vindicate this point.

Mega race for biologics and vaccines:

Driven by the above factor, in 2009 Pfizer acquired Wyeth for US $68 billion, Roche acquired Genentech for US $ 47 billion and Merck acquired Schering-Plough for US $ 41 billion. Only the above three M&A are valued more than US $ 150 billion and that too at a time of global financial meltdown.

Acquisition of Wyeth enabled Pfizer to expand its product-mix with vaccines, animal health and consumer products businesses and at the same time leveraging from Wyeth’s biologics capability.

Similarly, Merck got tempted to acquire Schering-Plough mainly because of latter’s rich R&D pipeline with biologics.

Roche, which was basically a pharmaceutical company, post-acquisition of Genentech, became a major bio-pharmaceutical company with a great promise to deliver in the years ahead.

Other M&As, which would signify a shift toward the growing space for biologics are the acquisition of MedImmune by AstraZeneca and Insmed by Merck and the recent bid of Sanofi-Aventis for Genzyme.

Faster growth of biologics:

As mentioned above, despite patent cliff, biologics continue to contribute better than small molecules to overall growth of the R&D based global pharmaceutical industry.  Most of these biologics are sourced either through acquisition or  collaborative arrangements.

Currently cash strapped biotech companies with molecules ready for human clinical trials or with target molecules in the well sought after growth areas like, monoclonal antibodies, vaccines, cell or gene therapies, therapeutic protein hormones, cytokines and tissue growth factors, etc. are becoming attractive acquisition targets, mainly by large pure pharmaceutical companies with deep pockets.

Another M&A model:

Besides mega race for mega acquisitions, on the other hand, relatively smaller pharmaceutical players have started acquiring venture-backed biotech companies to enrich their product pipelines with early-stage drugs at a much lesser cost. For example, with the acquisition of Calistoga for US $ 600 million and venture-backed Arresto Biosciences and CGI Pharmaceuticals, Gilead known for its HIV drugs, expanded into blood cancer, solid tumor and inflammatory diseases. In 2009 the same Gilead acquired CV Therapeutics for US $1.4billion to build a portfolio for cardiovascular drugs.

Smaller biotech companies, because of their current size do not get engaged in  very large deals, unlike the top pharma players, but make quick, decisive and usually successful deals.

Another commercial advantage for biologics – lesser generic competition :

After patent expiry of a New Chemical Entity (NCE), innovators’ brands become extremely vulnerable to cut throat generic competition with as much as 90% price erosion, as these small molecules are relatively easy to replicate by many generic manufacturers and the process of getting their regulatory approval is not as stringent as biosimilar drugs in most of the markets of the world.

On the other hand biologics, which involve difficult, complex and expensive biological processes for development together with stringent regulatory requirements for getting marketing approval of biosimilar drugs especially in the developed markets of the world like, EU and USA, offer some significant brand protection from generic competition for quite some time, even after patent expiry.

It is for this reason, brands like the following ones are expected to go strong for some more time to come, without any significant competition from biosimilar drugs:

Brand Company Launch date
Rituxan Roche/Biogen idec 1997
Herceptin Roche 1998
Remicade Centocor/J&J 1998
Enbrel Amgen/Pfizer 1998

Change of appetite:

In my view, the voracious appetite of large pharmaceutical companies for inorganic growth through mega M&As, will ultimately subside for various compelling reasons.  Instead, smaller biotech companies, especially with products in Phase I or II of clinical trials without further resource to take them to subsequent stages of development, will be prime targets for acquisition by the pharma majors at an attractive valuation.

Conclusion:

Although the large pharma majors are experimenting with pure biotech companies in terms of acquisitions and alliances, it will be interesting to see the long term ‘DNA Compatibility’ between these companies’ business models, organization and work/employee culture and market outlook to improve their overall global business performance, significantly. Only future will tell us whether or not just restructuring of the R&D set up of companies like, Pfizer, Merck, Roche and perhaps Sanofi-aventis at a later date, helps synergizing the overall R&D productivity of the merged companies.

In this context, Frost & Sullivan had commented: “Widely differing cultures at Roche and Genentech could make retaining top scientists a huge challenge. Roche is Swiss and a stickler for precision and time, while Genentech has a more ‘Californian attitude’ and is laid back and efficient in its work”.

Though the long-term overall financial impact of the ‘mega race for mega deals’, as mentioned above, is less clear to me, acquisition of biotech companies, especially well thought through smaller ones, seems to be a pretty smart move towards inorganic growth by the global innovator companies.

By: Tapan J Ray

Disclaimer: The views/opinions expressed in this article are entirely my own, written in my individual and personal capacity. I do not represent any other person or organization for this opinion.

Biosimilars: Creating new vistas of opportunities for Indian Bio Pharmaceutical players in the global market.

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Biosimilar or follow-on biologic drugs market is fast evolving across the world with varying degree of pace and stages of developments. The global market for Bio-pharmaceuticals was around US$ 120 billion in 2008, as reported by IMS. However, total turnover of Biosimilar drugs in the regulated markets during the same period was just US$ 60 million.

Currently about 25% of New Molecular Entities (NMEs) under development are of biotech origin. Indian pharmaceutical majors like Dr. Reddy’s Laboratories (DRL), Reliance Life Science, Shantha Biotech, Ranbaxy, Biocon, Wockhardt and Glenmark have made good investments in biotech drugs manufacturing facilities keeping an eye on the emerging opportunities with Biosimilar drugs in the developed markets of the world.

International Scenario:

Internationally most known companies in the Biosimilar drugs space are Teva, Stada, Hospira and Sandoz.

The first R&D focused global pharmaceutical company that expressed interest in this space is Merck & Co. In December 2008 Merck announced creation of ‘Merck Bio Venture’ for this purpose with an investment commitment of around US$ 1.5 billion by 2015.

Other large research based global innovator pharmaceutical companies, which so far have expressed interest in the field of Biosimilar drugs are Pfizer, Astra Zeneca and Eli Lilly.

Future market Potential:

IMS Health, July 2009 reports that only in the US from 2009 to 2013 about 8 major biologic products like for example, Enbrel (Amgen/J&J), Lovenox (Sanofi-Aventis), Zoladex (AstraZeneca), Mabthera (Roche), Humalog (Eli Lilly) and Novorapid (Novo Nordisk) are expected to go off patent. The sum total of revenue from these drugs will be over U.S$ 15 billion.

This throws open immense opportunities for the Indian companies working on Biosimilar drug development initiatives.

Regulatory pathway for Biosimilar drugs:

Currently EU is the largest Biosimilar market in the world. Immense healthcare cost containment pressure together with a large number of high value biologics going off patent during next five years, especially in the developed western markets like US and EU, are creating a new vista of opportunities in this field to the potential players.

Regulatory pathway for Biosimilar drugs exists in the European Union (EU) since 2005. In the USA President Barak Obama administration has already expressed its clear intention to have similar pathway established in the country through the US-FDA, which is expected to come by 2010.

Steps taken by the Indian pharmaceutical companies towards this direction:

Biosimilar version of Rituxan (Rituximab) of Roche used in the treatment of Non-Hodgkin’s lymphoma has already been developed by DRL in India. Last year Rituxan clocked a turnover of over US$ 2 billion. DRL also has developed filgastrim of Amgen, which enhances production of white blood-cell by the body, and markets the product as Grafeel in India. Similarly Ranbaxy has collaborated with Zenotech Laboratories to manufacture G-CSF. Meanwhile Biocon of Bangalore has commenced clinical trial of Insugen for the regulated markets like EU.

On the other hand Glenmark is planning to come out with its first biotech product by 2010 from its biological research establishment located in Switzerland.

Within Biopharmaceuticals the focus is on Oncology:

Within Biopharmaceuticals many of these domestic Indian pharmaceutical companies are targeting Oncology disease area, which is estimated to be the largest segment with a value turnover of over US$ 55 billion by 2010 growing over 17%. As per recent reports about 8 million deaths take place all over the world per year due to cancer. May be for this reason the research pipeline of NMEs is dominated by oncology with global pharmaceutical majors’ sharp R&D focus and research spend on this particular therapy area. About 50 NMEs for the treatment of cancer are expected to be launched in the global markets by 2015.

Indian market for oncology products:

Current size of the Indian oncology market is around US$ 18.6 million, which is expected to be over US$ 50 million by the end of 2010; the main reason being all these are and will be very expensive products. Biocon has just launched its monoclonal antibody based drug BIOMAb-EGFR for treating solid tumours with an eye to introduce this product in the western markets, as soon as they can get regulatory approval from these countries. Similarly, Ranbaxy with its strategic collaboration with Zenotech Laboratories is planning to market oncology products in various markets of the world like Brazil, Mexico, CIS and Russia.

Conclusion:

As the R&D based global innovator companies are now expanding into the Biosimilar space, many Indian domestic pharmaceutical companies are also poised to leverage their R&D initiatives on Biosimilars drugs development to fully encash the emerging global opportunities in this space. It is quite prudent for the Indian players to focus on the Oncology therapy area, as it is now the fastest growing segment in the global pharmaceutical industry.

By Tapan Ray

Disclaimer: The views/opinions expressed in this article are entirely my own, written in my individual and personal capacity. I do not represent any other person or organization for this opinion.

Biosimilars –Indian Pharmaceutical Companies are sharpening their focus on fast growing Oncology segment

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The global market for Bio-pharmaceuticals is estimated to be around US$ 50 billion by the next year. Currently about 25% of New Molecular Entities (NMEs) under development are of biotech origin. Indian pharmaceutical majors like Dr. Reddy’s Laboratories (DRL), Reliance Life Science, Shantha Biotech, Ranbaxy, Biocon, Wockhardt and Glenmarkhave made good investments in biotech drugs manufacturing facilities keeping an eye on the emerging opportunities with Biosimilar drugs in the developed markets of the world.
Regulatory pathway for Biosimilar drugs:
Already a regulatory pathway for Biosimilar drugs exists in the European Union (EU). In the USA President Barak Obama administration has already expressed its clear intention to have similar pathway established in the country through the US-FDA, which is expected to come by the end of this year.

Steps taken by the Indian pharmaceutical companies towards this direction:

Copycat version of Rituxan (Rituximab) of Roche used in the treatment of Non-Hodgkin’s lymphoma has already been developed by DRL in India. Last year Rituxan clocked a turnover of over US$ 2 billion. DRL also has developed filgastrim of Amgen, which enhances production of white blood-cell by the body, and markets the product as Grafeel in India. Similarly Ranbaxy has collaborated with Zenotech Laboratories to manufacture G-CSF. Meanwhile Biocon of Bangalore has commenced clinical trial of Insugen for the regulated markets like EU. All these initiatives are being taken in India.

On the other hand Glenmark is planning to come out with its first biotech product by 2010 from its biological research establishment located in Switzerland.

Within Biopharmaceuticals the focus is on Oncology:

Within Biopharmaceuticals many of these domestic Indian pharmaceutical companies are targeting Oncology disease area, which is estimated to be the largest segment with a value turnover of over US$ 55 billion by 2010 growing over 17%. As per recent reports about 8 million deaths take place all over the world per year due to cancer. May be for this reason the research pipeline of NMEs is dominated by oncology with global pharmaceutical majors’ sharp R&D focus and research spend on this particular therapy area. Thus about 50 NMEs for the treatment of cancer are expected to be launched in the global markets by 2015.

Indian market for oncology products:

Current size of the Indian oncology market is US$ 18.6 million, which is expected to be over US$ 50 million by the end of 2010; the main reason being all these are and will be very expensive products. Biocon has just launched its monoclonal antibodybased drug BIOMAb-EGFR for treating solid tumours with an eye to introduce this product in the western markets, as soon as they can get regulatory approval from these countries. Similarly, Ranbaxy with its strategic collaboration with Zenotech Laboratories is planning to market oncology products in various markets of the world like Brazil, Mexico, CIS and Russia.

Conclusion:

From the available information it appears that many Indian domestic pharmaceutical companies are now poised to leverage their R&D initiatives on Biosimilars. Oncologies being one of the fastest growing therapy segments, sharp focus on this area is indeed a step in the right direction.

By Tapan Ray

Disclaimer: The views/opinions expressed in this article are entirely my own, written in my individual and personal capacity. I do not represent any other person or organization for this opinion.