MedCity News October 30, 2025
Generic drugs don’t need lengthy clinical trials to support a submission seeking FDA approval. The regulator now proposes ending this testing requirement for biosimilars, products that reference complex biologic medicines.
The Trump administration’s latest effort to lower drug costs is expanding to biosimilars, medications that are highly similar to biologic medications made with or isolated from living organisms such as cells. Just as a generic drug is a less expensive version than a brand name product, biosimilars are lower-cost versions of complex biologic medicines. But there are key differences in how these medicines are tested and reviewed.
Generic medications, such as small molecules formulated as pills, only need to show bioequivalence to the reference product, the original drug. No clinical...
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