FDA, aiming to lower drug costs, moves to speed approval of biosimilars

BioPharma Dive October 29, 2025
Jonathan Gardner

The agency will no longer require studies comparing copycat biologics to their branded counterparts, which could help developers bring them to market more quickly and cheaply.

Dive Brief:

• The Food and Drug Administration wants to speed the development of biosimilars, announcing new guidance on Wednesday that would no longer require the makers of copycat biologics to run human trials showing their products are as effective and safe as their branded counterparts.
• The FDA agency said the policy shift should make biosimilar development faster and cheaper, estimating that companies could now save $100 million in development costs per product. At a press conference, Commissioner Martin Makary said the move could help create “more competition [and] more choices” for people who...

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