30 Oct 2025 | 5 Mins Read

US FDA speeds biosimilar approvals to boost domestic sales

Flipitmoney

The USFDA issued new draft guidelines to simplify and speed up biosimilar development, reducing costly studies and allowing analytical testing. This move could benefit Indian companies such as Biocon, Dr. Reddy's Laboratories, Lupin, and Sun Pharma, enhancing their presence in the US biosimilars market. Shares of these companies have seen gains in recent weeks.