Biosimilars vs. Interchangeable Biological Products: FDA Fact Check
XTalks
FEBRUARY 8, 2021
Unlike small-molecule generic drugs, biosimilars do not need to demonstrate bioequivalence to the innovator product. This replaces the previous approval pathway for insulin drugs and their analogs which have historically been reviewed as new drug applications under section 505(c) of the Federal Food, Drug, and Cosmetic Act (FD&C Act).
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