By Donald Zuhn --
Since President Obama signed the Patient Protection and Affordable Care Act into law in March, thereby establishing an approval pathway for biosimilar biological products, the biotech industry has waited to see which company might be the first to take advantage of the new approval pathway. Last week, Pfizer Inc. joined a growing list of candidates when it announced that it had entered into a strategic global agreement with India's largest biotech company, Biocon Ltd., for the worldwide commercialization of Biocon's biosimilar versions of Insulin and Insulin analog products: Recombinant Human Insulin, Glargine, Aspart, and Lispro.
Under the terms of the agreement, Pfizer will have exclusive rights to commercialize Biocon's Insulin products globally, with certain exceptions, including co-exclusive rights with Biocon for all of the products in Germany, India and Malaysia, and co-exclusive rights with existing Biocon licensees for some of the products. Biocon will retain responsibility for the clinical development, manufacture, and supply of the biosimilar Insulin products, and for securing regulatory approval for these products in various countries. Biocon has secured approval for its Recombinant Human Insulin in 27 countries and has launched its Glargine product in India. Pursuant to the agreement, Pfizer will pay Biocon $200 million, with Biocon receiving up to $150 million in additional milestone payments as well as additional payments linked to Pfizer's sales of the four Insulin biosimilar products.
David Simmons, president and general manager of Pfizer's Established Products Business Unit, said the collaboration "supports our stated efforts to become a strong player in follow-on biologics as well as in the Diabetes disease area, by adding to Pfizer's broad biotherapeutics portfolio, ranging from biosuperiors to biosimilars, across multiple therapeutic areas." The release noted that a number of Insulin analogs are expected to lose patent protection by 2015, "resulting in a significant opportunity for the biosimilars market," and that the agreement will allow the companies "to be well positioned to be first movers in this potentially large market opportunity."
Pfizer's announcement noted that diabetes affects nearly 230 million people worldwide and causes 3 million deaths annually, with the number of afflicted individuals expected to rise to 400 million by 2030. According to the release, the diabetes pandemic has impacted both the developing and developed world, as evidenced by the 18 million diabetic patients in the U.S. (a number expected to rise to 30 million by 2030). In the U.S., an estimated $200 billion is spent annually treating the disease.
After the details of the Pfizer-Biocon deal were released, Biocon announced that it would be investing $161 million on the research and development and production of high-end biosimilars in Malaysia (see International Business Times report). In particular, Biocon will be investing with the Malaysian Biotechnology Corp. to construct a facility that is expected to be operational by 2014.
Additional information regarding the agreement between Pfizer and Biocon can be found in Biocon's press release.
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