Biocon India Receives US FDA Approval for Biosimilar

India’s Bangalore-based Biocon Ltd is the country’s first company to have a “biosimilar” approved in the U.S. for Roche’s drug Trastuzumab, marketed as Herceptin, and used in treating certain breast and stomach cancers.

Biocon Ltd.

Kiran Mazumdar-Shaw, the company’s chairperson and managing director said, “This was the first biosimilar for Herceptin approved by the US FDA. It was a proud milestone for us because there are competitors, including Pfizer, Merck and Amgen, with deeper pockets and more experience in developing and selling biologics, which says a lot about what our scientists have done. It’s recognition that India has the skills to develop such complex molecules. It puts India on the global map of biosimilars.”

The biosimilar, which will be sold under the brand name Ogivri, brings Biocon a step closer to building a truly original bio-drug, or ‘novel biologic’ for various markets. Biocon already has two novel biologics—Nimotuzumab for treating head and neck cancer and Itolizumab for treating psoriasis—that it markets in India, added Mazumdar-Shaw.

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Posted on by Gunjan Bagla
Gunjan Bagla
California-based management consultant Gunjan Bagla runs Amritt, a consulting firm helping American companies to succeed in India. Amritt is the trusted advisor for India market research, India business development, India market entry, Global Engineering, Global Technology Scouting, India R&D and Open Innovation. Gunjan is author of "Business in 21st Century India: How to Profit Today from Tomorrow’s Most Exciting Market" (Hachette Book Group, 2008), Amazon's top rated title on the subject. He has appeared as the India Expert on BBC Television, Bloomberg TV, Fox Cable Business and has been quoted in the New York Times, the Los Angeles Times, the Hollywood Reporter and Business Week for his expertise on India.


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