What is a biosimilar?

A biosimilar is an FDA‑approved biologic medicine that is highly similar to an already‑approved reference product, with no clinically meaningful differences in safety, purity, or potency. While biosimilars may have minor differences in inactive components, they must meet rigorous analytical and clinical standards before they can be approved.

How are biosimilars evaluated?

The FDA uses a totality‑of‑evidence approach assessing:

  • Structural and functional similarity

  • Pharmacokinetics and pharmacodynamics

  • Clinical immunogenicity

  • Safety and efficacy data (as needed)

What is the difference between biosimilars and generics?

Generics are chemically synthesized and identical copies of small‑molecule drugs.
Biosimilars are made from living cells and cannot be identical, but must be highly similar.
Biosimilars are not generic drugs; they follow a distinct regulatory pathway.

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