Tag Archives: Complex

Focus More To Create Patient-Perceived Value of Brand Outcomes

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Healthcare providers, including many drug companies aim to create a beneficial effect on patients with their respective products and services. However, and more importantly, these benefits need to be such that recipients are able to sense, feel, and perceive as they expect – or may often go much beyond their expectations.

In this endeavor, when the perceived value of health care offerings exceeds the perceived cost of the products or services, the beneficiaries get naturally delighted. Conversely, when the perceived cost of the product weighs more than the perceived benefits, especially when it is incurred in lieu of some other essential living expenses, the patients accept the benefits grudgingly – without having any choice, or alternatives. The situation often fuels growing healthcare activism, across the globe and more involving expensive patented products.

Such expectations of many customers have increases manifold during Covid-19 pandemic, as many studies highlight. Thus, creating a win-win situation while aiming for a beneficial effect on patients, would call for in-depth understanding of the complex changes in the value delivery process. This is critical for all in the health care environment, and particularly the pharma marketers.

In today’s article, I shall dwell on some recent developments in this area, beginning with the basic need for in-depth understanding of the complex changes in the value delivery process. This process flows from ascertaining what have and have not changed in pharma industry’s new normal. The core intent is to find an answer to the key question: Should markers now need to focus much more on creating patient-perceived value of brand outcomes to business excellence?

Understanding complex changes in the value delivery process:

In today’s scenario – amid expressive customers, to get to know the needs, wants and expectations of the target audience, pharma marketers would need to listen to them carefully, and capture the same as they are – in an organized way. In-depth analysis of the data, thus captured, would help marketers chart a cutting-edge strategic pathway – converting data into actionable insights, in pursuit of excellence.

Covid-19 pandemic expanded digital media use even by older age group: 

Many studies have shown, since the onset of Covid-19 pandemic, the use of digital media for various purposes, including health care products ad services, has increased among older age groups, more than ever before.

One such April 2021 Press Release of AARP Research was captioned, ‘Tech Usage Among Older Adults Skyrockets During Pandemic.’ It reported, technology enabled older adults, to better weather – the isolation of the pandemic, started using digital platforms and social media, from ordering groceries to telehealth visits to connecting with loved ones.

More specifically, in the present context, the study found, among others - ‘50+ use of smartphones increased dramatically. For instance, use for ordering groceries grew from 6% to 24%; use of personal health increased from 28% to 40% for activities like telehealth visits, ordering prescriptions, or making appointments; use of health and fitness information increased 25% to 44%; and use of financial transactions increased 37% to 53%.’

Another AARP publication on September 2021 was captioned: ‘Personal Tech and the Pandemic: Older Adults Are Upgrading for a Better Online Experience.’ It also articulated: ‘Texting, email, social media, and video chatting have become commonplace as the COVID-19 pandemic has forced people to remain home, separated from friends and family. More than 80% of those 50-plus said they use technology in some form to stay connected, many on a daily basis.’

I hasten to add that the above study, although was conducted in the United States, the overall trend is expected to be similar in India – of course, with varying numbers. Be that as it may, the new opportunity of listening to customers from their reach, use, interactions, and conversations through digital channels, and sieving out relevant information from the same, needs to be adequately leveraged.

This space could provide high-quality data, when used in a structured manner, for in-depth understanding of the pandemic-triggered changes in customer dynamics. No wonder, why some major pharma players’ greater focus on listening intently to healthcare customers’ conversation is assuming increasing criticality, today. This process would also help immensely while delivering value of affordable access to contemporary innovative drugs.

Increasing criticality of affordable access to contemporary innovative drugs:

Alongside the pre-Covid 19 ailments, new disease complications in the pandemic – or, now, in endemic-prone areas, would enhance manifold the criticality of the value of access to innovative drugs – for all to be up and running. This area, was well articulated in a similar context in the article, published in the Pharmaceutical Executive on September 20, 2021.

The authors reiterated, ‘Patient affordability and access enablement, along with health system sustainability and affordability, are critical factors that impact current patient access to these innovations as well as sustained future access to new innovations.’

Many pharma companies, who have both resources and knowledge to develop and supply new and innovative medicines at scale, are already talking about it, even in the new normal. But, they would now need to walk the talk with a greater sense of inclusivity that can be seen and felt by all. Let me cite a very recent example in this area from the Covid-19 perspective.

A recent example in this area from Covid-19 perspective:

An encouraging recent development about affordable access to innovative drugs was reported by The New York Times on October 27, 2021. It reported: ‘Merck has granted a royalty-free license for its promising Covid-19 pill to a United Nations-backed nonprofit in a deal that would allow the drug to be manufactured and sold cheaply in the poorest nations, where vaccines for the coronavirus are in devastatingly short supply.’

More, such examples, also involving treatment in other critical disease areas, would have a salutary effect, even on the public image of the concerned pharma innovators. The ball seems to have started rolling in this direction, as evident from the key findings of the ‘2021 Access to Medicine Index’.

‘2021 Access to Medicine Index’ elucidates the point:

The ‘2021 Access to Medicine Index’, published by the Access to Medicine Foundation, on January 26, 2021, reiterates the increasing criticality of affordable access to contemporary innovative drugs. It adds, with the resources and the knowledge to develop and supply new medicines at scale, pharma players have a responsibility to ensure these are made available to people regardless of their socioeconomic standing.

The key findings of the report include the following:

  • Eight companies adopt processes to systematically address access to medicine for all new products
  • Less than half of key products are covered by pharma companies’ access strategies in poorer countries.
  • R&D for COVID-19 has increased, yet another pandemic risk goes unaddressed.

In sync with other experts, the report further emphasizes, ‘Pharmaceutical companies have the power to address affordability by refining their access strategies; and the ability to strengthen supply chains and support healthcare infrastructures. Considering their size, resources, pipelines, portfolios and global reach, these companies have a critical role to play in improving access to medicines.’

Why affordable access to innovative drugs is more critical in India:

The much-deliberated issue of why affordable access to innovative drugs is so critical in India, was aptly analyzed in an article, published by Brookings on March 03, 2020. The backdrop of the discussion was the W.H.O data on global health expenditures that compares out-of-pocket expenditure (OOPE) as a proportion of current health expenditure.

It revealed, India does much worse in comparison to the world average of OOPE. This was 65% for India versus the world average of around 20%, in 2016, with a similar scenario as compared to other Asian countries.  It specified, Thailand and China have reduced the proportion of OOPE over time, while Sri Lanka and Bangladesh witnessed an increase over time.

Conclusion:

The current healthcare spectrum of possibilities to address these issues haven’t changed significantly, since then. Interestingly, this is despite the increasing need of innovative drugs that’s keeping pace with the complexity in the health care environment since the onset of Covid-19 pandemic.

Thus, the criticality of affordable access to contemporary innovative drugs in the new normal, deserves an out of the box solution. Even today, OOPE continues to remain very high in India, and mostly for outdoor patient treatments. Thus, it is imperative that pharma marketers should focus more to create greater patient-perceived (not self-perceived) value of brand outcomes, in an innovative way – for business excellence in the new normal.

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.

Would ‘Complex Generics’ Attract More ‘Authorized Generics’?

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Despite increasing numbers of alleged scams involving generic drugs, both in the United States and also in India, even involving many large generic drug manufacturers, the traditional generic drug market, keeps growing globally. Although, the current growth is in mid-single digit, the market can’t be ignored, either.

That apart, enormous pricing pressure, squeezing bottom line and cutthroat competition, are prompting many companies, including Big Pharma, to craft different strategies to excel in this market. One such involves a shift in business focus from relatively low priced traditional generic drugs to comparatively higher priced complex or specialty generic medicines with a few competitors.

In this emerging situation, a lurking apprehension does surface for many. If the margin is good and the prices of these complex or specialty generics, are much higher than traditional ones, won’t it prompt more ‘Authorized Generics’ coming into the market? Won’t that jeopardize the interest of other generic drug makers? In this article, I shall explore this area, along with its possible consequences. Before doing that, it will be worthwhile to give an overview of the generic market, before recapitulating what are ‘Authorized’ and ‘Complex’ generics.

How lucrative is the generic drugs market now?

According to the latest report by IMARC Group, the global generic drug market size reached US$ 340 Billion in 2018 and is expected to be at US$ 475 Billion by 2024, growing at a CAGR of 5.3 percent during 2019-2024 period.

The key market growth drivers remain, increasing number of product patent expiration, higher prevalence of chronic diseases and different government initiatives to encourage faster generic launch, including the United States. The pace of increase is faster in the emerging markets, like India. However, unlike India, non-branded generic drugs, rather than branded generics, are dominating most the markets.

Although, Central Nervous System (CNS), cardiovascular, dermatology, oncology and respiratory are among the dominant segments in the market, CNS and Cardiovascular segments are the two largest ones in this market. North America holds the largest market share, with more than 88 percent of total prescriptions being written for generic drugs in the U.S., as the report highlights. Despite this scenario, to mitigate huge pricing pressure, cutthroat competition and low margin, many drug players are preparing to move into specialty or complex generics.

The size and growth of complex or specialty generics market: 

The April 2019 report by Research and Markets- “Specialty Generics Market: Global Industry Trends, Share, Size, Growth, Opportunity and Forecast 2019-2024″ states, the global specialty generics market reached a value of US$ 44.8 Billion in 2018. By 2014, its value is expected to reach US$ 88.9 Billion with a much higher CAGR of 11.9 percent, in 2019-2024 period.

Which drugs would belong to this market?

According to the ‘White Paper’ titled, ‘Complex Generics: Maximizing FDA Approval Prospects’ of Parexel, the following are some examples of complex generics; the list continues to grow as more products are being added in this category every day:

  • Complex Active Pharmaceutical Ingredients (APIs), examples being Enoxaparin, Low Molecular Weight Heparin, Glatiramoids, Iron Carbohydrate Complexes etc.
  • Complex Formulations, examples being Liposomes, abuse-deterrent generics, parenteral microspheres.
  • Complex Route of Delivery, such as topical ointments and locally acting GI drugs.
  • Complex Drug-Device Combinations, such as DPI, MDI, nasal sprays, and transdermal systems.

These types of complex and high-cost generics, besides some off-patent biologic products and even Biosimilar drugs, are often used to treat complex and life-threatening diseases, such as, cancer, Hepatitis C, and many others. Complex generics are expected to eventually own a significant percentage of the total generic drugs market, as a number of big-ticket specialty drug molecules will go off patent in the ensuing years.

The major advantages of complex generics:

Some of the major advantages of the complex generics market over traditional generics are as follows:

  • Complex manufacturing requirements with higher capital costs – thus, higher price, better margin, fewer players, lesser competition.
  • Increasing prevalence of life-threatening diseases, besides, cost containment measures from the government and healthcare providers, are pushing the demand of these drugs.

Indian companies are also entering the fray: 

As the share of specialty medicines in global spending in 2017 increased to 32 percent from 19 percent in 2007, Indian drug players also could sniff the opportunity in this space. Just as Sun Pharma, reportedly shifted its focus from once lucrative traditional generics medicines to specialty drugs, amid continued price erosion in its biggest market – the US, many others are also joining the fray.  The Indian players who are, reportedly, investing in complex generics include, Aurobindo Pharma, Dr. Reddy’s Labs, Cipla, Lupin, Glenmark and Cadila.

More specifically, with the contribution of specialty medicines to overall pharmaceutical spend in the US, Germany, France, Italy, UK, and Spain – almost doubling over the last 10 years, this trend is likely to gather momentum, as the above report indicated. Accordingly, commensurate strategic actions aimed at this segment by many companies, both global and local, are clearly now visible.

Some strategic initiatives:

In preparation of a major shift in the strategic focus on complex generics, key examples of some of the important initiatives of different companies will include the following:

  • Big generic players wanted to be bigger in the global market through M&A, such as Teva acquired Allergan’s generic business, Mylan bought Abbott Laboratories’ generics businessAbbott Laboratories’ non-U.S. developed markets specialty and branded generics business. Similarly, Endo International acquired Par Pharmaceuticals. In India the mega deal of Sun Pharma acquiring Ranbaxy in 2015. In the same year, Lupin acquired New Jersey-based generic drugs firm GAVIS to boost its presence in the US.
  • Novartis sold its 300 ‘troubled’ U.S. generics to India’s Aurobindo for US$ 1B, as the entire generics industry faced unrelenting pricing pressure in the U.S.’ Whereas, Novartis’ wants to focus higher-margin assets like Biosimilars and complex generics.
  • Pfizer is set to combine its off-patent drug unit Upjohn with Mylan, to create a new business with its own off-patent branded and generic drug lines. The merger will bring together Pfizer medications such as Lipitor and Viagra with Mylan’s EpiPen, used to halt life-threatening allergic reactions.
  • Owing to margin pressure and other reasons, some of the Indian drug players also decided to enter into higher margin complex generics space, pursuing both organic and inorganic routes. There are several such examples, such as: In January 2017, Zydus Cadila announced acquisition of Sentynl Therapeutics Inc., a US based specialty pharma company specialized in marketing of products in the pain management segment. And in October 2017, Lupin acquired US-based Symbiomix Therapeutics LLC to expand Lupin’s US women’s health specialty business in the highly complementary gynecological infection sector.

Any flip side of complex generics business for the Indian players? 

Although, driven by mainly higher profit margins and tough entry barriers, many generic players with the requisite wherewithal, find complex generics business more attractive to focus on, there’s a flip side to it, as well. This is, post patent expiry, innovator companies may be encouraged to introduce more ‘Authorized Generics’, creating a tough competitive environment for other generic players to compete with them. This brings us to the question of what are ‘Authorized Generics?’

Authorized Generics:

According to the USFDA, the term ‘Authorized generic’ is used to describe an approved brand name drug that is marketed without any brand name on its label. It is exactly the same product as the branded one, and may also be marketed by another company with the innovator company’s permission. Generally, an ‘Authorized Generic’ is launched at a lower price than the brand name drug.

Moreover, ‘Authorized Generics’, despite being the generic version of patented molecule, are mostly marketed by the patent holders themselves, both pre and post patent expiry. While a separate NDA is not required for marketing an ‘Authorized Generic’, USFDA requires that the NDA holder notify the FDA, if it markets an ‘Authorized Generic. The NDA holder may market both the ‘Authorized Generic’ and the brand-name product at the same time. Interestingly, the USFDA has approved around 1215 ‘Authorized Generics’ as of September 30, 2019.

Advantages of ‘Authorized Generics’ over ‘Traditional Generics’:

The key advantage of ‘Authorized Generics’ over traditional generic drugs is, while traditional generic drugs can be marketed only after patent expiry of the innovator drug, ‘Authorized Generics’ can be marketed even before patent expiry. In other words, innovator companies or their authorized collaborators can make lower priced ‘Authorized Generic’ versions available on their behalf, under their own new drug application (NDA). ‘Authorized Generics’ may be made available to patients even before patent expiry to out-maneuver the conventional generic drug makers, in advance, on price, quality and doctors’ confidence in the original drug.

According to several reports, over the past years, ‘many innovator drugs companies have been launching Authorized Generics, simultaneously with the first Abbreviated New Drug Applications (ANDA) filer’s launch of its generic drug product.’ However, the question remains how do the stakeholders perceive the ‘Authorized Generics’?

Perception of ‘Authorized Generics’:

Studies are available analyzing the impact of ‘Authorized Generics’ on the pharma market and also on the stakeholders. In this article, I shall refer to a comprehensive research study, titled ‘Authorized Generics: Effect on Pharmaceutical Market,’ published in the International Journal of Novel Trends in Pharmaceutical Sciences (IJNPTS), on February 29, 2012, which came out with the some notable findings.

Generally, there isn’t any doubt, either on the fact that ‘Authorized Generics’ provide the identical experience that the patient receives from the brand drug but at a lower price. Nor is there any question over greater confidence of doctors while prescribing these drugs. However, the researchers wrapped up the discussion by stating: It is difficult to conclude that the ‘Authorized Generics’ practice should be continued or banned. Though Indian pharmaceutical companies are dealing with generic drugs – 42 percent of the respondents were in favor of ‘Authorized Generics’ practice, whereas 58 percent opposed it. Thus, the overall perception of ‘Authorized Generics’, appears to be a mixed bag.

Conclusion:

There are free flowing arguments both in favor and against the ‘Authorized Generics.’ The article titled, ‘Drugmakers Master Rolling Out Their Own Generics to Stifle Competition,’ published in the Kaiser Health News (KHN) on August 05, 2019, captures it well.

It quoted the spokeswoman for the Pharmaceutical Research and Manufacturers of America, or PhRMA, a powerful pharma lobby group saying, an Authorized Generic drug “reduces prices and results in significant cost savings.” Whereas the critics say, “Authorized Generics hurt long-term competition and often perversely increase costs, even in the short term.”

The detractors further expressed, ‘Authorized Generics’ don’t just steal sales from existing generic rivals, they erode incentives to make generic drugs. A professor at the University of California, Hastings College of the Law, who studies pharma was also quoted in this article saying, this practice can “stave off generic competition and make sure that generics can’t get much of a foothold when they do get to market.” Adding further he said: “That’s the game. And drug companies have become masters at this.”

As the Kaiser Health News highlighted, Eli Lilly announced launch of the ‘Authorized Generic’ version of Humalog insulin in March 2019 for US$137 a vial, at half the price of its brand name version costing US$237. This was reasoned by the company as a considerate move to address the need of those patients who can’t afford the price of the brand – Humalog. Curiously, even some analysts believe that ‘Authorized Generics’ may help explain why relatively few true generics are reaching the market despite a surge in approvals, especially in the United States.

Against the above backdrop, the drug policy makers need to ponder, would ‘complex generics’ of different companies face greater challenges from ‘Authorized Generics,’ playing a spoilsport for the rest in this ball game?

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.

 

 

Protect Generic Drug Margin Moving Up The Value Chain

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As an innovative drug molecule goes off-patent, it paves the way for market-entry of cheaper generic equivalents of the same. It benefits not just the patients, but all generic drug players awaiting this opportunity. But, in case of even those generic drugs enjoying 180-day exclusivity in the United States, the price erosion would still be significant, at least, 20 percent to 30 percent. Post 180-day exclusivity, intense competition between different formulations of the same molecule can bring the price down by even 85 percent or more, as compared to the original one.

While looking at the world’s largest pharma market, one sees an interesting scenario unfolding in this area. The Generic Access and Savings Report in the United States 2018 released on July 10, 2018 by the Association for Accessible Medicines, captures it well. Some of the key findings of which on generic drugs are as follows:

  • In 2017, generic medicines account for nine out of every 10 prescriptions filled in the United States.
  • Patients fail to fill their prescriptions for brand-name drugs at a rate 2-3 times higher than for generics.
  • 93 percent of generic prescriptions are filled at $20 or less.
  • Average patient copay for a generic prescription is $6.06.
  • Generic medicines generated a total of $265 billion in savings.

That’s a good story for the patients in general, and specifically for those who are in the United States. That said, there is a business aspect of this story, as well. In this article, I shall focus on that, venturing into the way forward. However, before proceeding further, for the understanding of all, let me briefly explain, what is this 180-day exclusivity period as described by the FDA in the United States (USFDA).

180-day exclusivity period for generic drug:

USFDA may grant some exclusivity to Abbreviated New Drug Applications (ANDAs) for generic drugs. For this purpose, under the Drug Price Competition and Patent Term Restoration Act, or the Hatch-Waxman Act, a company can seek approval from the FDA to market a generic drug before the expiration of a patent relating to the brand name drug upon which the generic is based. The first company to submit an ANDA with the FDA has the exclusive right to market the generic drug for 180 days. This is called 180-day exclusivity and:

  • Provides an incentive of 180 days of market exclusivity to the “first” generic applicant who challenges a listed patent by filing a paragraph IV certification and running the risk of having to defend a patent infringement suit.
  • Begins either from the date the sponsor begins commercial marketing of the generic drug product, or from the date of a court decision finding the patent invalid, unenforceable or not infringed, whichever is first.
  • In some circumstances, an applicant who obtains 180-day exclusivity may be the sole marketer of a generic competitor to the innovator product for 180 days
  • FDA does not send letters to the sponsor indicating the grant of exclusivity. The Orange Book is the official vehicle for dissemination of this information.

It is worth noting that some drugs have both patent and exclusivity protections while others have just one or none. Patents and exclusivity may or may not run concurrently and may or may not encompass the same claims.

Increasing pressure on margin:

Nevertheless, after 180-day exclusivity period or as in most other cases, cut-throat price competition starts among product proliferation. On the other hand, even after patent expiry, the prices of original brand name drugs keep attracting a substantial premium. According to another study: “Brand-name drugs have been shown to be priced 20 percent higher than generic drugs in the Netherlands, 30 percent higher in Germany, 50 percent higher in Canada, 50–90 percent higher in the US, and 80 percent higher in the UK.”

In today’s environment, generic drugs are under severe cost pressure also because of direct government interventions in many large markets, such as the United States. A couple of other factors also play a major role in squeezing the generic drug margin in several countries, such as:

  • Large wholesalers while fighting with each other to get the pharmacy business, often exert tough pressure on generic manufacturers to lower the price.
  • Other bulk buyers also do the same making the margin wafer-thin.

Its cumulative impact leads to commoditization of generic drugs.

Commoditization of generic drugs:

As is known to many, for a commodity there are many suppliers mostly without any tangible differentiating features and benefits. The same thing happens to generic medicines of the same molecule without any worthwhile difference in efficacy, quality and safety standards. Thus, the price of a generic formulation generally includes its total cost, plus a margin, and depends market demand and supply for products outside any price control. Intense competition within many players with more supply of the same molecule, often squeezes the margin out to a dangerous level.

This scenario was well captured in an 2018 article published in the Journal of Bioequivalence & Bioavailability (volume 10(3): 48-49 (2018) –48). It reiterated, cutthroat competition and public pressure pose challenges for ethical and generic pharma companies. 7 to 10 percent annual price erosion, increased competition coupled with other pressure push margins lower leading to decreased profitability.

Major costs did not change much:

Moreover, the major fixed costs involving raw materials, packing materials, labor and conversion expenditure did not change commensurately. The manufacturing process and yield improvement measures did help. But up to a certain point and not beyond that, to keep the quality of finished formulations within the accepted regulatory requirements of the respective countries, such as the United States.

The trend prevails in 2018: 

The above trend prevails even in 2018, in continuation with the previous year. One may recall that in August 2017, due to serious price erosion, several billion dollars in market value were wiped out for some top generic companies. These names include India’s homegrown Dr. Reddy’s Lab., besides Teva and Mylan.

The article titled, ‘Opportunities and Obstacles for Generic Drugs,’ published in PharmTechalso emphasized: ‘Continued pressure on generic-drug prices may reduce product development and limit manufacturing in the US. Numerous state officials have filed lawsuits against generic-drug makers for alleged price-fixing, and debate continues over brand vs. generic product labeling to warn consumers about safety issues. All these trends will shape generic-drug production and costs in the coming months.’

In this situation, the ability of the generic companies to find ways to increase their margin will be the key to success in this business, if not for a long-term survival too.

Ways to achieve it:

One of the novel ways to achieve this goal is entry into ‘Complex Generics’ business.

According to Market Realist – an independent investment research organization, ‘Complex Generics’ are attractive due to high margins. Unlike, commoditized generic formulations, ‘complex generics’ are not easy to manufacture and are generally used in specialty care, namely for treating serious chronic diseases or several life-threatening ailments, such as cancer, HIV or hepatitis C. To some extent complex generics create a market entry barrier for many generic players, due to higher manufacturing cost and complex processes involved in developing this genre of drugs.Complex generics may be classified into several categories, such as:

  • Complex Active Ingredients: like, peptides
  • Complex Formulations: like, liposomes, iron colloids
  • Complex Delivery System: like, locally acting drugs
  • Complex Drug-Device Combinations: like respiratory metered dose inhalers, transdermal system or a medicated adhesive patch
  • Biosimilar drugs

On October 09, 2018, a statement from USFDA Commissioner Scott Gottlieb highlighted a new effort to advance the development of generic copies of complex drugs to improve patient access to medicines. Gottlieb said, complex generics “aredrugs that, by nature of their formulation or delivery systems for example, are harder to ‘genericize’ under our traditional approaches. As a result, these drugs often face less competition. Today, we’re announcing a series of guidance documents that will advance the development of generic transdermal and topical delivery systems (TDS).”

This is an interesting development in the world’s largest pharma market.

Lucrative prices of complex generics:

Prices of complex generics are much higher than conventional generic drugs. According to Market Realist a complex generic could cost around US$ 6,000 per month to patients, but would still remain way below the cost of related original brand. Hence, it is a win-win situation – both for patients and also the generic drug manufacturers. Additionally, alongside benefiting patients in terms of cost, complex generics show potential to fetch higher profitability with a reasonable product differentiation.

The ball has started rolling:

It happened in a big way this year, when due to intense price pressure on generics, Sandoz division of Novartis took a major step. On September 6, 2018 - Novartis announced that it has agreed to sell selected portions of its Sandoz US portfolio, specifically the Sandoz US dermatology business and generic US oral solid portfolio, to Aurobindo Pharma USA Inc. It also said, ‘this transaction supports the Sandoz strategy of focusing on complex-generics, value-added medicines and biosimilars to achieve sustainable and profitable growth in the US over the long-term.’

Indian generic drug manufacturers have also sniffed this opportunity. Several Indian players, such as Sun Pharma, Cipla, Lupin, Reliance Life Science, Dr. Reddy’s Laboratories, Glenmark, Biocon and Aurobindo Pharma, to name a few, have made forays into complex generics, including biosimilars. All put together Indian companies have filed around 50 ANDAs in the United States. This number is good, but may not guarantee success for all the applicants. Only the quality of these ANDAs will determine how soon, or how late, or how expensive would be the process of getting marketing approval for complex generics in the United States.

Conclusion:

As ‘The Lancet Oncology’ editorial of June 2015 noted: ‘In recent years, generics manufacturers have increased investment in the development of complex generics.” I reckon, this won’t include a large number of drug exporters from India – not just yet.

The development process of complex generics isn’t everybody’s cup of tea. Thus, venturing into this area by any generic player of all sizes and scale, would call for greater commitment from the company concerned. This path is arduous as compared to conventional generics. If not navigated properly, cost may also be high in certain circumstances. For example, if and when the regulator asks more elaborate trial, or repeat trials, or even the marketing approval process itself could be tough to conform with. That said, complex generics are expected to eventually contribute a significant percentage of the generic market, as their approval challenges are overcome.

Be that as it may, to improve, if not for protecting the profitability of the generic drug business, transacted especially in the developed world, there doesn’t seem to be much option left now, but to move up the value chain.

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.