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Executive Q&A; they will go through a painful period of slow acceptance Q: What are some of the major challenges foreign drug makers over the next 10 years or so. But it is only a matter of time must overcome to successfully compete in the Indian life before biosimilar products will penetrate global markets as sciences market? aggressively as small-molecule generics have in recent years. Mazumdar-Shaw: One of the most challenging aspects of This is because national healthcare systems must seriously the Indian pharmaceutical market is drug pricing. Most of the begin to address the escalating costs of prescription drugs. drugs being developed by Western companies will simply be However, unlike generic small-molecule drugs, biosimilars too expensive to sell on the Indian market. This is forcing many face many tough challenges. multinational companies to consider dual pricing and branding First, some of the regulatory requirements for approval strategies; that is, they offer a lower price for India and other of biosimilars in the U.S. don't make rational sense. For emerging markets as compared with the rest of the world. While example, the stipulation of using a U.S. reference product the sheer size of the Indian market suggests this may be a only to establish biosimilarity begs to be questioned. viable strategy going forward, many multinational This regulatory requirement will undoubtedly pharmaceutical companies are still weighing raise the costs of developing biosimilar their pricing-strategy options. molecules for the U.S. market, which in Fragmentation of Indian supply and turn may likely lead to higher prices drug distribution chains is another for biosimilar drugs in the U.S. huge challenge for foreign drug Another big challenge is physician makers. For example, every state education. Until physicians are in India has a different set of clearly convinced of the safety regulations for drug distribution. and efficacy of biosimilars, they Also, the current system literally are unlikely to prescribe them supports hundreds of thousands to patients. Physicians need to of pharmacies and physicians with be convinced of the quality of a different local and regional needs. biosimilar as compared with its The Indian market is extremely branded counterpart. complex and the one-size-fits-all drug Perhaps one of the greatest challenges Kiran Mazumdar-Shaw, Biocon distribution model favored by Western for biosimilars will be whether or drug companies would be impossible to not these molecules are substitutable or implement in India. interchangeable with innovator products. Finally, penetration of the different markets While this is still a very contentious and a hotly that exist in India is also extremely challenging. For debated topic, I believe biosimilars will ultimately be example, the needs, infrastructure, and dynamics of Indian interchangeable or substituted for branded products and become urban markets are very different from those of the semi-urban part of standard medical practice in the future. markets, which are again markedly different from those of rural Another challenge is one of development cost. Current Indian markets. To be successful, foreign drug companies must guidelines mandate extensive comparative clinical studies, understand and embrace the differences of these markets and often larger in size than the innovator drug. It is imperative determine the best way forward for each of them. regulators evolve an abbreviated path that shrinks both the size and timeline to commercialize biosimilar drugs, or else the Q: What are your thoughts on the recent patent rulings objective of affordability will not be met. that many multinational pharma and biotech companies Finally, biosimilar products are already quite prevalent in many claim are making it increasingly difficult for foreign emerging markets. However, unlike the past, the countries that companies to compete in India? represent these markets are aggressively establishing regulatory guidelines for development and approval of biosimilar products. To Mazumdar-Shaw: The Indian government has been very clear that end, we recently submitted draft biosimilar guidance to the Indian from the beginning that it will not accept "evergreening" of regulatory authority that includes mandatory comparator clinical trials patents. The recent Indian court decision not to honor Novartis' for approval of biosimilars in India. Our goal is to ensure biosimilars Gleevec patent extension, in my opinion, was a clear example of manufactured in India are safe, efficacious, and of high quality. "I am concerned about India's willingness to implement compulsory licensing for certain drugs." 40 LifeScienceLeader.com August 2013