FDA Plans to Loosen Testing Rules to Boost Biosimilar Drugs

 

The US Food and Drug Administration is easing some requirements for drugmakers developing copycat versions of costly biologic medications in a bid to bring more competition to the market and lower costs.

The agency plans to reduce the need for some studies that demonstrate the drugs, called biosimilars, are equivalent to the brand-name medications they’re modeled on, according to an FDA official who asked not to be identified and a document reviewed by Bloomberg News. The agency estimates the change could shave $20 million from the cost of developing a new biosimilar drug.

https://www.bloomberg.com/news/articles/2026-03-09/fda-plans-to-loosen-testing-rules-to-boost-biosimilar-drugs