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adjective Referring to a biosimilar therapeutic agent 

noun A biopharmaceutical which is produced by a different manufacturer after the expiry of the patent and marketing exclusivity of an original innovative biological product–e.g., a therapeutic monoclonal antibody. 

In contrast to small (non-biological) agents, for which manufacturing an equivalent product is a relatively straightforward chemical process, biosimilars are not produced from the original clones and cell lines used to produce the tested and proven effective agent, thus may have a therapeutic and metabolic profile that differs from the clinically tested and proven product. 

Synonyms Follow-on biologic, similar biological medicinal products, subsequent entry biologic


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