USFDA May Relax Biosimilar Testing Requirements, Development Costs Could Drop by USD 20 Million
Bengaluru: The U.S. Food and Drug Administration plans to ease testing requirements for companies developing biosimilar drugs, Bloomberg News reported, citing an agency official and internal documents.
The FDA is expected to issue draft guidance as soon as Monday that would reduce the need for certain studies used to show that biosimilar medicines match the brand-name treatments they are based on, Bloomberg reported, citing an FDA official and a document it reviewed.
Unlike cheap generic versions of simple-to-manufacture pills, medicines made from living cells cannot be exactly copied, so are referred to as biosimilars.
The Department of Health and Human Services, which oversees the FDA, did not immediately respond to a Reuters request for comment outside regular working hours.
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