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dissolve the partnership was simply a business one that was in both parties’ best interest.

Question: You are an ardent supporter of biosimilar products. What are your views on the future of the global biosimilar market?

Answer: Biosimilars will go through a painful period of slow acceptance over the next 10 years or so, but I believe that it is only a matter of time before biosimilar products will penetrate global markets as aggressively as small molecule generics have in recent years. This is because national healthcare systems must seriously begin to address the escalating costs of prescription drugs. However, unlike generic small molecule drugs, biosimilars face many tough challenges.

First, some of the regulatory requirements for approval of biosimilars in the U.S. don’t make rational sense. For example, the stipulation of using a U.S. Reference Product only to establish biosimilarity

begs to be questioned. This regulatory requirement will undoubtedly raise the costs of developing biosimilar molecules for the U.S. market, which in turn, may likely lead to higher prices for biosimilar drugs in the U.S.

Another big challenge is physician education. Until physicians are clearly convinced of the safety and efficacy of biosimilars they are unlikely to prescribe them to patients. Physicians will need to be convinced of the quality of a biosimilar as compared to its branded counterpart. Because of a lack of education surrounding biosimilars, questions about the quality and safety of biosimilar molecules continue to persist among physicians.

Perhaps one of the greatest challenges for biosimilars will be whether or not these molecules are substitutable or interchangeable with innovator products. While this is still a very contentious and a hotly-debated topic,

I believe that biosimilars will ultimately be interchangeable or substituted for branded products and become part of standard medical practice in the future.

Finally, biosimilar products are already quite prevalent in many emerging markets. However, unlike the past, the countries that represent these markets are aggressively establishing regulatory guidelines for development and approval of biosimilar products. To that end, we recently submitted draft biosimilar guidances to the Indian regulatory authority that include mandatory comparator clinical trials for approval of biosimilars in India. Our goal is to ensure that biosimilars manufactured in India are safe, efficacious and of high quality.

Women in Pharma: Kiran mazumdar-ShaW - BioSimiLarS

Clifford S. Mintz, Ph.D. is the founder of BioInsights, Inc. and serves as its Chairman and CEO. He holds a Ph.D. in Bacteriology from the University of Wisconsin-Madison and is an expert in the fields of molecular biology, microbiology, and bioscience education.

BIOSIMILARS

Speaking with Kiran mazumdar-Shaw about the Emerging Indian Biotechnology Market

~ Part 2 ~

an interview WithKiran mazumdar-Shaw

by Clifford Mintz, PhD

Part II of this article concludes my interview with renowned businesswoman and Chairman and Managing Director of Biocon, Kiran Mazumdar-Shaw. Ms. Mazumdar-Shaw, as one of the most influential players in India’s biotechnology industry, sat down with me to discuss India’s role in the generic and biotechnology industries, as well as some of the challenges faced in this market.

Question: What are some of the major challenges that foreign drug makers must overcome to successfully compete in India’s life sciences market?

Answer: Unlike most of our competitors, Biocon has been almost exclusively focused on bringing biologics and biotechnology products to the Indian market. In addition, we have a fairly rich pipeline of novel programs. For example, we were the first company to bring a novel, clinically-tested humanized monoclonal antibody (BIOMAb EGFR) to the Indian market as a treatment for head and neck cancers. Further, we are actively involved in developing companion diagnostic products for oncology and a novel oral insulin and several novel monoclonal antibody drugs.

Finally, what mostly separates us from our competitors is our commitment to developing our products that comply with European and American clinical drug development paradigms. This is a very unique approach among Indian drug companies and it has helped to draw foreign interest in Biocon. While our

goal is to bring most of our own products to both the Indian and foreign markets, we are always open to partnering with other companies when it makes financial sense.

Question: Several years ago Biocon entered into a historic $350 million biosimilar insulin deal with Pfizer. Recently, the deal was dissolved. Are you able to comment about what led to the dissolution of the partnership?

Answer: As is the case for most large corporations, research priorities and business directions continually undergo change. With regard to our deal with Pfizer, their management felt that Biocon’s biosimilar insulins program was less attractive and had a lower ROI when compared with their internal biosimilar protein and antibody development programs. Consequently, we had very mature

business discussions about the deal and in the end both parties amicably agreed that dissolving the partnership was in everyone’s best interest. Pfizer was fair in terms of the financial settlement which allowed us to retain a significant portion of the upfront fees. This will allow Biocon to pursue its biosimilar insulins development on its own. Although we lost Pfizer as our main commercialization partner, we plan on commercializing biosimilar insulins with a variety of regional pharmaceutical partners in Mexico, Brazil and elsewhere that pre-dated the Pfizer deal. We will also seek new partners in other regions.

While some people may choose to speculate about the reasons behind the dissolution of our deal with Pfizer, the decision to

“I believe that it is only a matter of time before biosimilar products will penetrate global markets as aggressively as small

molecule generics have in recent years...”

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