Anticancer Drugs (11/01/2015) Vol. 26, No. 10, P. 1009; Pivot, X.; Aulagner, G.; Blay, J.Y.

The HER2-positive breast-cancer treatment trastuzumab will reach its European patent expiry in 2017, and numerous biosimilars are now in comparability exercises for marketing authorization. However, trastuzumab's nature as a monoclonal antibody, its impact on patient survival, and biochemical complexities could create barriers for biosimilars, report French researchers. There are still unresolved questions about how to evaluate biosimilars in several areas. These include clinical endpoint definitions for anticancer drugs, assessment pathways and comparative testing of biosimilars, and immunogenicity monitoring among immunocompromised patients. The French parliament recently approved biosimilar substitution, which would allow for the dispensing of trastuzumab biosimilars in place of the originator. The authors report that an expert panel has been established examine the challenges of trastuzumab biosimilars.

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