Medscape November 21, 2025
The FDA has proposed new policies to speed up the development and lower the cost of biosimilar agents for cancer and other serious illnesses.
These policies include “major updates to simplify biosimilarity studies and reduce unnecessary clinical testing” and “a separate initiative…to make it easier for biosimilars to be developed as interchangeable with brand-name biologics,” the agency stated in a recent press release.
How Does the FDA Plan to Streamline the Biosimilar Drug Approval Process?
A draft guidance issued by the FDA in October for “comment purposes only” provides updated recommendations for industry on assessing the need for comparative efficacy studies (CESs) for biosimilar agents.
“Generally, if the [comparative analytical assessment] supports a demonstration that the proposed biosimilar is highly...
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