Indian pharmaceutical companies are set to gain from the US Food and Drug Administration's changed stance on biosimilar versions of biological medicines. With the US FDA approving a biosimilar interchangeable insulin product for the treatment of diabetes for the first time in the country, the doors appear to have been opened for generic players, with many considering it a shot in the arm, reports The Pharma Letter’s India correspondent.
Semglee (insulin glargine-yfgn), manufactured by Biocon Biologics (BSE: 532523), a Bengaluru-based company, is both interchangeable with and biosimilar to Lantus (insulin glargine), a long-acting insulin product from Sanofi (Euronext: SAN) already approved in the USA. The US FDA move will allow pharmacists to automatically substitute the cheaper version, just as they do with generic pills, and is expected to save millions of dollars annually as well as encourage other drug makers to create more biosimilar medicines.
Indian drugmakers are banking on the fact that the US FDA move not only endorses the high quality of biosimilars produced in India, but it also speaks volumes of the scientific skill prevalent in the country.
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