Term
Biosimilar
A biologic approved as highly similar to an already-licensed reference biologic, with no clinically meaningful differences.
Biologics are large molecules made in living systems, so an exact copy is impossible; a biosimilar instead demonstrates, through analytical and clinical comparison, that it is highly similar to the reference product and performs the same in patients. That makes it a different regulatory object from a small-molecule generic, which is an exact chemical copy.
Under this site's asset-identity rule, a biosimilar is its own asset: its own marketing application, its own owner, its own page, cross-linked to the reference product it tracks.
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