biosimilar(redirected from subsequent entry biologic)
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Highly similar in function and effect to an existing biological product, especially to a biologic that has already been clinically tested and approved for use.
A biological product that is biosimilar to an existing product, especially to a biologic.
biosimilaradjective Referring to a biosimilar therapeutics agent.
noun A biopharmaceutical which is produced by a different manufacturer after the expiration 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; they thus may have therapeutic and metabolic profiles that differ from the clinically tested and proven products.
biosimilar(bi?o-sim'i-lar) [ bio- + similar]
1. A generic version of a biologically active pharmaceutical agent, e.g., of a manufactured antibody or hormone.
2. Pert. to such a generic version.Synonym: follow-on biologicbiosimilarity