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.
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.
Last updated: December 26th, 2025
