FDA plans to relax testing rules to encourage biosimilar drugs: report

2026-03-09 06:44:09 ET

• The U.S. Food and Drug Administration is reportedly 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 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. The FDA is expected to issue draft guidance as ?soon as Monday.

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