Biosimilar
/ˈbaɪoʊˌsɪmələr/
Definitions
- (n.) A biologic medical product highly similar to an already approved reference product, with no clinically meaningful differences in safety or effectiveness.
The FDA approved the biosimilar after confirming its equivalence to the original biologic drug.
Forms
- biosimilar
- biosimilars
Related terms
See also
Commentary
In legal contexts, biosimilars often involve complex patent and regulatory issues distinct from generic drugs due to the complexity of biologics.
This glossary is for general informational and educational purposes only. Definitions are jurisdiction-agnostic but reflect terminology and concepts primarily drawn from English and American legal traditions. Nothing herein constitutes legal advice or creates a lawyer-client relationship. Users should consult qualified counsel for advice on specific matters or jurisdictions.