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Create Novel Marketing Pathways As Covid Mutants Keep Emerging

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The World’s battle against wave after wave unsettling onslaught of Coronavirus on human lives and livelihood continues, since December 2019. The first wave was triggered by the novel Covid-19 from Wuhan in China, the second by its deadly – Delta variant, and now – the third by Omicron. In India, first case of Covid-19 was reported on January 31, 2020.

Initially, global experts contemplated vaccines to prevent and contain Covid-19 and were the best hope for ending the pandemic. However, the effectiveness of existing Covid vaccines apparently declines against its subsequent mutants. This is evident even in India when the next variant Omicron commenced its onslaught.

The good news is, AstraZeneca has now claimed, a third booster shot of its Covid-19 vaccine willsignificantly boost antibody levels against the Omicron variant. However, Omicron may not be the last Covid-19 variant, as it appears today.

As the world grapples with the highly mutated Omicron, scientists have identified another new strain of the COVID-19 causing virus – in Southern France – known as ‘IHU’. This B.1.640.2 variant was reported by researchers at institute IHU Mediterranee Infection in at least 12 cases. However, it is too early to speculate on how this variant behaves as far as infection and protection from vaccines is concerned. This process is likely to take, at least, some more time.

Thus, in the current situation, when increasing numbers of even fully vaccinated individuals are getting re-infected caused by emerging mutants of Covid-19, and some more than once, the focus expanded towards more effective disease treatment. Some countries, such as the US, have decided for the 3rd booster shot of Covid-19 vaccine. Israel has even gone for the 4th booster shot of Covid vaccine. Be that as it may, in this fast-evolving scenario, even bright pharma marketers have been experiencing new strategic challenges, as we move on. Against the above backdrop, this article will delve into that space, focusing on some of the new trends of the new normal.

Pharma’s focus expands towards more effective Covid specific treatment:

Visualizing the way Covid-19 pandemic could possibly pan out in the foreseeable future, several global pharma and biotech companies have started focusing on specific treatment for this virus, ensuring speedy patient recovery.

For example, on November 21, 2020, the U.S. FDA issued an emergency use authorization (EUA) for a cocktail therapy of casirivimab and imdevimab for the treatment of mild to moderate COVID-19 in adults and pediatric patients.

Just a month later, on December 22, 2021, the U.S. FDA issued another emergency use authorization (EUA) for Pfizer’s (nirmatrelvir tablets and ritonavir tablets, co-packaged for oral use). This was also for the treatment of mild-to-moderate coronavirus disease (COVID-19) in adults and pediatric patients.

A day after Pfizer’s the first oral COVID-19 treatment, approval, on December 23, 2022, the U.S. FDA issued one more emergency use authorization (EUA) for Merck’s molnupiravir. This is the second antiviral pill authorized in the U.S, for the treatment of mild-to-moderate coronavirus disease (COVID-19) in adults. Nearer home, the Drug Controller General of India (DCGI) has also given EUA to Molnupiravir for the treatment of adult patients.

Interestingly, French regulators rejected Merck’s molnupiravir pill for low efficacy. They found other therapies were much more effective than this molecule. Even in India on January 06, 2022, the Indian Council of Medical Research (ICMR) also expressed safety concerns on Molnupiravir. Thus, it has not been included in the national list of Covid treatments in India. That said, such brilliant initiatives by several pharma companies in the battle for saving lives and livelihoods against Covid-19 pandemic, made those companies household names like never before.

Covid made several pharma companies household names, but not brands:

This point was restated in a recent article, published in the Fierce Pharma on December 22, 2021. It emphasized, Covid-19 ‘has brought the words of the pharma industry into people’s lives like never before: Moderna, Pfizer, BioNTech, AstraZeneca and Merck have become household names.’ One may not remember the names of their Covid products, but will mostly know the company.

Many people have now started referring to Covid vaccines and drugs in generic names. As from the very beginning we started hearing people saying, like – I got ‘AstraZeneca Vaccines’, ‘Remdesivir’, or ‘Covid Cocktail therapy’. Company names usually followed the generic names in most cases. Although, ‘that’s been good for pharma’s reputation, but has left marketers in a bind about branding, commented the above article.

Most Covid-19 drugs and vaccine brands are on ‘emergency use approval’

In the Covid dominated year of 2021, drug and biotech companies managed to get USFDA approval for 55 new drugs. However, many of those drugs and vaccines got only Emergency Use Approval (EUA) and only under emergency use basis. This basically means, under EUA these companies did not get full marketing approval and were handicapped to go whole hog with the usual new brand marketing campaigns.  This critical issue is expected to remain even in 2022.

In a situation, such as this, when the full scale branding initiatives can’t be undertaken, intenseCorporate Branding Campaigns, I reckon, would pay a rich dividend. This process will be quite different from creative new brand marketing in the old normal. Some global innovator companies are using even the mass media to promote their respective vaccines, albeit differently.

Such promotions include, Open Letter from the Company CEO, creative use of TV shows, messages of the head honchos through twitter or word of mouth campaigns – creating a snowballing effect. Alongside, healthcare marketing professionals are also intensifying their Covid-vaccine ad campaigns, sans brand names, to increase awareness and persuade more people to get vaccinated, soon.

To move in this direction, at least, during EUA period for Covid drugs and vaccines, hybridization of pharma marketing will be necessary in many cases, which won’t be an easy task for all, though.

Hybridization of pharma marketing – necessary – but not an easy task:

Based on experience of almost the last two years, many drug companies have realized that virtual-only customer engagement models have some serious shortcomings to fetch desired outcomes. This issue was studied and well-articulated in an article, published in the Reuters Events on November 30, 2021.

It found: “Virtual-only engagement can make it harder to create a real connection.” Further, as the paper articulated: “Even if HCPs share their video, we are losing the third dimension, hence losing out on parts of that personal component.’ Besides, although, online meetings are flexible regarding timing, if a doctor doesn’t dial-in, there is only a small chance the meeting will happen later that day, unlike waiting in a clinic for the interview to take place.

To address this issue, pharma players are now in various stages of creation and adoption of their respective hybrid marketing models. However, the process offers its own challenges. Working out customer-specific hybrid engagement models are a different ball game altogether- requiring very different skill sets, continuous training and above all a very different mindset.

Conclusion:

As reported on January 06, 2022, rapidly spreading Omicron variant of the novel Coronavirus threatens to rewrite the business recovery timelines, even in India. Even recently, many CEOs and top executives have opined, businesses would have to live with Covid-19 uncertainty. The article further added: ‘Many companies have suspended their return-to-work plans and are reassessing business continuity measures as a third wave of the pandemic starts to surge.’ Most CEOs also expressed one of their top priorities was to ensure Covid-19 protocols were being followed and all employees were safe.

Similar situation arises for all Covid drugs approved under the EUA by the Drug Controller general of India, and are being marketed by Indian companies against non-exclusive voluntary licensing agreements with the innovators. Thus, an analogous marketing issue exists surrounding all such EUAs, as the company concerned can’t undertake a full brand marketing campaign. This constraint is likely to pose a major marketing challenge for several potential Covid blockbuster drugs in India, at least in 2022, which marketers need to overcome, creatively.

From the above perspective of Covid-19 drugs and vaccines, companies would need to create novel and effective strategic pathways for performance excellence. At least, as long as Covid-19 mutants will continue to emerge, causing operational disruptions in the pharma business.

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.

 

Is India A Success Story With Biosimilar Drugs?

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How Indian generic companies are expanding, if not shifting their business focus on biosimilar and complex generic drugs, may be a current trend of general discourse – but the initiative is not a current one. This journey commenced decades ago with an eye on the future. In those days, Indian players were already dominating the global markets of small molecule generic drugs. Interestingly, it started much before the big global players decided to enter into this segment – especially post patent expiry of large molecule blockbuster drugs.

This strategy not just exhibits a sound business rationale, but also benefits patients with affordable access to biosimilar versions of high cost biologic drugs. In this article, I shall dwell on this subject, basically to understand whether India is a success story with large molecule biosimilar drugs, both in terms of drug development, and also in its commercial performance.

India’s journey began with the dawn of the new millennium:

About two decades back from now, some Indian pharma companies decided to step into an uncharted frontier of large molecule biosimilar drugs. According to the ‘Generics and Biosimilars Initiative (GaBI)’, in 2000 – the first biosimilar drug, duly approved by the Drug Controller General of India (DCGI), was launched in the country.  This was hepatitis B vaccine from Wockhardt – Biovac-B.

I hasten to add, in those years, there were no specific regulatory pathways for approval of large molecule biosimilar drugs in India. Thus, the same marketing approval guidelines as applicable to small molecule generic drugs, used to be followed by the DCGI for this purpose. Specific guidelines for biosimilar drugs were implemented on September 15, 2012, which was subsequently updated in August 2016. To date, around 70 large molecule biosimilar drugs, including biopharmaceuticals, have been introduced in India, as the GaBI list indicates.

It is equally important to note that well before any other countries, domestic pharma companies launched in India, AbbVie’s blockbuster Humira (adalimumab) and Roche’s breast cancer treatment Herceptin (trastuzumab). In this context, it is worth mentioning that US-FDA approved the first biosimilar product, Zarxio (filgrastim-sndz), in March 2015.

Will India be a key driver for global biosimilar market growth?

According to the Grand View Research Report of July 2018, increasing focus on biosimilar product development in countries, such as India, China and South Korea, is a major growth driver of the global biosimilar market. As this report indicates, the global biosimilars market size was valued at USD 4.36 billion in 2016, which is expected to record a CAGR of 34.2 percent during 2018-25 period.

Europe has held the largest revenue market share due to a well-defined regulatory framework for biosimilars was in place there for quite some time, and was followed by Asia Pacific (AP), in 2016. Growing demand for less expensive therapeutic products and high prevalence of chronic diseases in the AP region are expected to contribute to the regional market growth – the report highlighted.

Further, the Report on ‘Country-wise biosimilar pipelines number in development worldwide 2017’ of Statista also indicated that as of October 2017, India has a pipeline of 257 biosimilar drugs, against 269 of China, 187 of the United States, 109 of South Korea, 97 of Russia and 57 of Switzerland. However, post 2009 – after biosimilar regulatory pathway was established in the United States, the country has gained significant momentum in this segment, presenting new opportunities and also some challenges to biosimilar players across the world.

Is Indian biosimilar market growth enough now?

An important point to ponder at this stage: Is Indian biosimilar market growth good enough as of now, as compared to its expected potential? Against the backdrop of India’s global success with generic drugs – right from the initial stages, the current biosimilar market growth is certainly not what it ought to be. Let me illustrate this point by drawing an example from theAssociated Chambers of Commerce of India’s October 2016 White Paper.

According to the Paper, biosimilars were worth USD 2.2 billion out of the USD 32 billion of the Indian pharmaceutical market, in 2016, and is expected to reach USD 40 billion by 2030. This represents a CAGR of 30 percent. A range of biologic patent expiry in the next few years could add further fuel to this growth.

A similar scenario prevails in the global market, as well. According to Energias Market Research report of August 2018, ‘the global biosimilar market is expected to grow significantly from USD 3,748 million in 2017 to USD 34,865 million in 2024, at a CAGR of 32.6 percent from 2018 to 2024.’

Many other reports also forecast that the future of biosimilar drugs would be dramatically different. For example, the ‘World Preview 2017, Outlook to 2022 Report’ of Evaluate Pharma estimated that the entry of biosimilars would erode the total sales of biologics by as much as 54 percent through 2022, in the global markets. It further elaborated that biologic sales may stand to lose up to USD 194 billion as several top blockbuster biologic drugs will go off-patent during this period.

Although, current growth rate of the biosimilar market isn’t at par with expectations, there is a reasonable possibility of its zooming north, both in India and the overseas markets, in the near future. However, I would put a few riders for this to happen, some of which are as follows:

Some uncertainties still exist:

I shall not discuss here the basic barriers that restrict entry of too many players in this segment, unlike small molecule generics. Some of which are – requisite scientific and regulatory expertise, alongside wherewithal to create a world class manufacturing facility a complex nature. Keeping those aside, there are some different types of uncertainties, which need to be successfully navigated to succeed with biosimilars. To get an idea of such unpredictability, let me cite a couple of examples, as hereunder:

1. Unforeseen patent challenges, manufacturing and regulatory issues:

  • Wherewithal to effectively navigate through any unexpected labyrinth of intricate patent challenges, which are very expensive and time-consuming. It may crop up even during the final stages of development, till drug marketing, especially in potentially high profit developed markets, like for biosimilars of Humira (AbbVie) in the United States or for Roche’s Herceptin and Avastin in India.
  • It is expensive, time consuming and risk-intensive to correct even a minor modification or unforeseen variation in the highly controlled manufacturing environment to maintain quality across the system, to ensure high product safety. For example, what happened to Biocon and Mylan with Herceptin Biosimilar. As the production volume goes up, the financial risk becomes greater.
  • There are reports that innovator companies may make access to supplies of reference products difficult, which are so vital for ‘comparability testing and clinical trials.’  This could delay the entire process of development of biosimilar drugs, inviting a cost and time-overrun.
  • Current regulatory requirements in various countries may not be exactly the same, involving significant additional expenditure for overseas market access.

2. User-perception of biosimilar drugs:

Studies on perception of biosimilar vis-à-vis originator’s biologic drugs have brought out that many prescribing physicians still believe that there can be differences between originator’s biologic medicine and their biosimilar equivalents. With drug safety being the major concern of patients, who trust their physician’s decision to start on or switch to a biosimilar, this dilemma gets often translated into doctors’ preferring the originator’s product to its biosimilar version. One such study was published in the September 2017 issue of Bio Drugs. Thus, the evolution of the uptake of biosimilars could also depend mainly on similar perception of physicians.

What happens if this perception continues?

Whereas, the W.H.O and drug regulators in different countries are quite clear about comparable safety and efficacy between the originator’s product and its biosimilar variety, some innovator companies’ position on biosimilar drug definition, could help creating a perception that both are not being quite the same, both in efficacy and safety.

To illustrate this point, let me reproduce below how a top ranked global pharma company - Amgen, defines biosimilar drugs, starting with a perspective of biologic medicines:

“Biologic medicines have led to significant advances in the treatment of patients with serious illnesses.These medicines are large, complex molecules that are difficult to manufacture because they are made in living cells grown in a laboratory. It is impossible for a different manufacturer to make an exact replica of a biologic medicine due to several factors, including the inherent complexity of biologics and the proprietary details of the manufacturing process for the original biologic medicine, often referred to as the reference product.It is because of this that copies of biological products are referred to as “biosimilars”; they are highly SIMILAR but not identical to the biologic upon which they are based.”

Could dissemination of the above concept through a mammoth sales and marketing machine to the target audience, lead to creating a better perception that the originators’ biologic drugs are better than their biosimilar genre?

Other realities:

Despite the availability of a wide array of biosimilar drugs, the prescription pattern of these molecules is still very modest, even in India. One of its reasons, as many believe, these are still not affordable to many, due to high out-of-pocket drug expenses in India.

Thus, where other biosimilars of the same category already exist, competitive domestic pricing would play a critical role for faster market penetration, as happens with small molecule generic drugs.

Another strategic approach to address cost aspect of the issue, is to explore possibilities of sharing the high cost and risks associated with biosimilar drug development, through collaborative arrangements with global drug companies. One good Indian example in this area is Biocon’s collaboration with Mylan.

Conclusion:

The question on whether Indian biosimilar market growth is good enough, assumes greater importance, specifically against the backdrop of domestic players’ engagement in this segment, since around last two decades. Apart from the important perception issue with biosimilars , these medicines are still not affordable to many in India, owing to high ‘out of pocket’ drug expenditure. Just focusing on the price difference between original biologic drugs and their biosimilars, it is unlikely to get this issue resolved. There should be enough competition even within biosimilars to drive down the price, as happened earlier with small molecule generics.

That said, with around 100 private biopharmaceutical companies associated with development, manufacturing and marketing of biosimilar drugs in India, the segment certainly offers a good opportunity for future growth. Over 70 such drugs, most of which are biosimilar versions of blockbuster biologic, are already in the market. Today, Indian companies are stepping out of the shores of India, expecting to make their presence felt in the global biosimilar markets, as they did with generic drugs.

The future projections of biosimilar drugs, both in the domestic and global markets are indeed very bullish. But to reap a rich harvest from expected future opportunities, Indian players would still require some more grounds to cover. Overall, in terms of biosimilar drug development since 2000, India indeed stands out as a success story, but a spectacular commercial success with biosimilars is yet to eventuate.

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: The Roadblocks and the Road Ahead

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Unlike commonly used ‘small molecule’ chemical based drugs, ‘large molecule’ biologic drugs are developed from living cells and using very complex processes. These groups of drugs could range from simpler insulin to therapy for treating complex ailments like, cancer and almost invariably attract a high price tag, which could run even in thousands of dollars.

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. These drugs are usually much less expensive than the original ones and called ‘Biosimilar Drugs’. It is expected that ‘biosimilar drugs’ will have lesser market competition than the conventional ‘small molecule’ generic drugs, mainly because of complexity and costs involved in their developmental process.

Future growth potential:

In most of the developed countries, besides regulatory issues, ‘Biosimilar drugs’ are considered to be a threat to the fast growing global biotech industry. At the same time, it is widely believed that in the rapidly evolving global concern for cheaper and more affordable medicines for patients across the world, relatively smaller biotech companies, given the required wherewithal  at their disposal, could emerge as winners in this new ball game as compared to traditional generic pharmaceutical players.

Novartis (Sandoz) – first to launch a ‘Biosimilar drug’ in the US:

In mid-2006, US FDA approved its first ‘Biosimilar drug’- Omnitrope of Sandoz (Novartis) following a court directive. Omnitrope is a copycat version of Pfizer’s human growth hormone, Genotropin. Interestingly, Sandoz had also taken the US FDA to court for keeping its regulatory approval pending for some time in the absence of a well-defined regulatory pathway for ‘Biosimilar drugs’ in the USA. The CEO of Sandoz had then commented, “The FDA’s approval is a breakthrough in our goal of making high-quality and cost-effective follow-on biotechnology medicines like Omnitrope available for healthcare providers and patients worldwide”. Despite this event, none at that time expected the US FDA to put regulatory guidelines in place for approval of ‘Biosimilar drugs’ in the country.

Merck’s entry was through an acquisition:

Merck announced its entry into the ‘Biosimilar drugs’ business on February 12, 2009 with its acquisition of Insmed’s portfolio for US$ 130 million in cash. Rich pipeline of follow-on biologics of Insmed is expected to help Merck to hasten its entry into global ‘Biosimilar drugs’ markets.

Other recent global initiatives:

  • Merck paid US$ 720 million to Hanwha for rights to its copy of Enbrel of Amgen
  • Samsung of South Korea has set up a biosimilars joint venture with Quintiles to create a contract manufacturer for biotech drugs.
  • Celltrion and LG Life Sciences have expressed global ambitions in biosimilar drugs.
  • Dr Reddy’s Laboratories (DRL) has already been marketing a biosimilar version of Rituxan of Roche since 2007.
  • According to Reuter (June 22, 2011), Merck, Novartis (Sandoz), Teva and Pfizer are expected to be strong players in the biosimilar market.
  • Reliance Life Science though has faced a setback in Europe with the regulators asking for more data for its copy of EPO prompting them to withdraw their application for now, is also a potential player in the biosimilar market.

Many other developments are also now taking place in the space of ‘Biosimilar drugs’, the world over. To fetch maximum benefits out of this emerging opportunity, India has started taking steps to tighten its regulatory process for marketing approval of such drugs. This is absolutely necessary to allay general apprehensions on drug safety with inadequate clinical data for similar protein substances.

Current status in the US:

President Barak Obama administration of the US has been expressing for quite some time a strong intent to pave the way for ‘Biosimilar drugs’ in the US. To facilitate this process, a new draft legislation titled, “Promoting Innovation and Access to Life Saving Medicine Act” was introduced by the legislators of the country. This legislation came into force with the announcement by US-FDA the outline of how biopharmaceutical players can submit their application for marketing approval of ‘Biosimilar drugs’ in the country. Many industry players have since then been gearing up, across the world, to have a share of the potentially large ‘biosimilar drugs’ market in the US.

Challenging clinical data requirements in the US:

According to ‘Biologics Price Competition and Innovation Act of 2009 (BPCI Act)’, which was enacted in the US on March 23, 2010, any biological substance to be “biosimilar” will require to be “highly similar to the reference product, notwithstanding minor differences in clinically inactive components”. BPCI also specifies that there should be “no clinically meaningful differences between the biological product and the reference product in terms of the safety, purity, and potency of the product”. It is interesting to note that the Act emphasizes on ‘clinical similarity’ rather than ‘biological or structural similarity’ between the original and ‘biosimilar drugs’.

The New England Journal of Medicine dated August 4, 2011 reported that US-FDA is in the process of establishing very challenging clinical requirements from the makers of ‘biosimilar drugs’ for obtaining marketing approval in the country. Such stringent regulatory requirements are expected to push up the cost of development of ‘biosimilar drugs’ significantly, seriously limiting the number of players in the market.

12 years Exclusivity in the US:

In the US, the innovator companies get 12 years exclusivity for their original biologic drugs from the date of respective marketing approvals by the FDA.

The BPCI Act clearly specifies that applications for ‘biosimilar drugs’ to the FDA will not be made effective by the regulator before 12 years from the date of approval of the innovators’ products. In addition, if the original product is for pediatric indications, the 12-years exclusivity may get an extension for another six months.

However, the key point to note here is, if the FDA starts its review process for the ‘biosimilar drugs’ only after the 12 year period, the innovator companies in that case, will effectively get, at least, one more year of exclusivity over and above  the 12 years period, when the applicants for ‘biosimilar drugs’ will keep waiting for marketing approval from the FDA.

The market:

According to Datamonitor the global market for ‘biosimilars drugs’ is expected to grow from US$ 243 million in 2010 to around US $3.7 billion by 2015.

Another report points out that only in the top two largest pharmaceutical markets of the world, the USA and EU, sales of ‘biosimilar drugs’ will record a turnover of US$ 16 billion in the next couple of years when about 60 biotech products will go off-patent.

The Indian biotech players:

Such a lucrative business opportunity in the west is obviously attracting many Indian players, like, Biocon, Dr. Reddy’s Labs, Ranbaxy, Wockhardt, Shantha Biotech, Reliance Life Science etc., who have already acquired expertise in the development of ‘Biosimilar drugs’ like, erythropoietin, insulin, monoclonal antibodies, interferon-Alfa, which are not only being marketed in India but are also exported to other non/less-regulated markets of the world.

Ranbaxy in collaboration with Zenotech Laboratories is engaged in global development of Granulocyte Colony-Stimulating Factor (GCSF) formulations. Wockhardt is expected to enter into the Global ‘Biosimilar drugs’ market shortly. Dr. Reddy’s Laboratories and Biocon are also preparing themselves for global development and marketing of insulin products, GCSF and streptokinase formulations.

Funding by the Government of India:

It has been reported that the Department of Biotechnology (DBT) of the Government of India has proposed funding of US$ 68 million for ‘biosimilar drugs’ through Public Private Partnership (PPP) initiatives, where soft loans will be made available to the Indian biotech companies for the same. Currently DBT spends reportedly around US$200 million annually towards biotechnology related initiatives.

Key success factors for rapid acceptance in the developed markets:

According to a new research finding from ‘The Decision Resources’, one of the key success factors for any such new drugs is how quickly the specialists will accept them. So far as biosimilar drugs are concerned they noted a high level of concern, if such drugs are not supported by robust sets of clinical data on the claimed treatment indications.

Conclusion:

With increasing global cost-containment pressures within the healthcare space, the emergence of a lucrative global ‘biosimilar drugs’ market now appears to be inevitable.

In the fast evolving scenario, major research based global bio-pharma and even the pure pharmaceutical companies will have two clear choices. The first choice is the conventional one of competing with ‘biosimilar drugs’ in all important markets of the world. However, the second choice of jumping into the fray, keeping undiluted focus on R&D, appears to be more prudent and perhaps will also make a shrewd horse sense. Only future will tell us, which of these two business senses will prevail, in the run up to success, for the global biotech companies.

With the above background, the report from the ‘Business Wire’ highlighting the fact, ‘the manufacture and development of a biosimilar molecule requires an investment of about US$ 10 to 20 million in India, as compared to US$ 50 to 100 million in developed countries’, vindicates the emergence of another lucrative business opportunity for India.

With around 40% cost arbitrage, as indicated above and  without compromising on the required stringent international regulatory standards, the domestic ‘biosimilar’ players  should be able to establish India as one of the most preferred manufacturing destinations to meet the global requirements for ‘biosimilar drugs’.

Experience in conforming to stringent US FDA manufacturing standards, having largest number of US FDA approved plants outside USA, India has already acquired a clear advantage in manufacturing  high technology chemical based pharmaceutical products in India. Significant improvement in conformance to Good Clinical Practices (GCP) standards will offer additional advantages.

In addition to cost efficiency, available skill sets in developing ‘biosimilar drugs’, will offer another critical advantage to the domestic players in reaching out to the international ‘biosimilar drugs’ markets either by themselves or with appropriate collaborative arrangements, just as we have recently witnessed in case of Biocon’s strategic collaboration with Pfizer in this rapidly evolving sector of the world.

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.