biosimilar

(redirected from Follow-on Biologic)
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biosimilar

(bī′ō-sĭm′ə-lər)
adj.
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.
n.
A biological product that is biosimilar to an existing product, especially to a biologic.

biosimilar

adjective 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
References in periodicals archive ?
In 2010, to encourage price competition and innovation in markets for biologics, Congress passed the Biologics Price Competition and Innovation Act (BPCIA), which established an abbreviated regulatory pathway for the approval of follow-on biologics by the Food and Drug Administration.
Because of provisions in the current US biosimilar regulations, generics may not be incentivized to use the abbreviated pathway but instead file a BLA for follow-on biologic products, just as Teva did in 2009.
Other topics likely to be covered by the guidance include the interchangeability of follow-on biologics with the source biologic and testing requirements for the comparability of follow-on biologics.
However, the broader legal and public policy debate surrounding follow-on biologics has stymied the agency's efforts to set forth scientific guidelines.