FDA nod to company’s biosimilar drug is encouraging for other Indian pharma companies in the same space
KIRAN MAZUMDAR-Shaw’s Biocon Ltd recently surpassed a significant milestone, winning the first approval from the United States Food and Drug Administration (USFDA) for a biosimilar drug from India. The nod, for a biological substance used to treat certain types of breast and stomach cancer, is seen as a landmark decision by the biopharma industry.
“Extraordinary. It’s an absolute landmark because the biosimilar guidelines in the US have been so tough,” says Vijay Chandru, chairman and managing director of Strand Life Sciences. Chandru, a professor at Bengaluru’s Indian Institute of Science, is a pioneering entrepreneur in the Indian biotech research ecosystem, and has previously led the Indian biotech lobby, Association of Biotechnology Led Enterprises (Able).
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