WASHINGTON — The Trump administration announced a draft framework Wednesday that officials say will speed cheaper versions of biologic drugs to market with the aim of making medicine more affordable and accessible for patients.
The framework will shorten the path for the Food and Drug Administration to approve biosimilars, or copycat versions of biologic drugs, by lowering the clinical standards companies need to meet before bringing the drugs to market.
That will cut the cost of developing biosimilars and the time needed to approve them, FDA Commissioner Marty Makary said at an announcement about the change. Makary said the agency plans to release its final guidance on biosimilars in three to six months.
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