Biosimilar

Definisi

A biologic drug that is highly similar to an already approved reference biologic product, with no clinically meaningful differences in safety, purity, or potency. Unlike generics (which are chemically identical), biosimilars are structurally similar because biologics are too complex to replicate exactly.

Contoh

Adalimumab-atto (Amjevita) is a biosimilar to Humira, offering similar efficacy for rheumatoid arthritis at a lower cost.

Istilah Terkait

Generic Equivalence Generic Drug Biologic Drug

Disebutkan dalam Panduan

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