Biosimilar
A biologic product highly similar to an already-approved reference biologic.
Definition
A biosimilar is a biologic medicine highly similar to an already-approved reference biologic, with no clinically meaningful differences in safety, purity, or potency. Unlike small-molecule generics, biosimilars require their own approval pathway (351(k) in the US) and analytical, non-clinical, and limited clinical data. Approved biosimilars include adalimumab, infliximab, and trastuzumab biosimilars.
See also
- BLA — Biologics License Application — the FDA submission required for biologics (proteins, antibodies, gene therapies).
- Generic drug — A bioequivalent copy of a small-molecule drug after its patent and exclusivity expire.