Challenges in the implementation of trastuzumab biosimilars: an expert panel's recommendations

Anti-cancer Drugs
Xavier PivotSamuel Limat

Abstract

Trastuzumab has transformed the treatment of HER2-positive breast cancer. Because of impending European patent expiry in 2017, numerous trastuzumab biosimilars are currently undergoing comparability exercises for marketing authorization. Although biosimilar products have been approved in Europe since 2006, many obstacles are expected for trastuzumab, resulting from its nature as a monoclonal antibody, its impact on overall survival, and its extensive biochemical complexities. Unsolved questions need to be addressed for the evaluation of biosimilars' activity in terms of appropriate clinical endpoint definitions for such anticancer drugs, specific assessment pathways and comparative testing of biosimilars, untested ensuing de facto combination of trastuzumab biosimilars with cytotoxics, and immunogenicity monitoring among immunocompromised patients. In such a context of uncertainties, the recent approval by the French parliament of biosimilar substitution, which would allow dispensing trastuzumab biosimilars in place of the originator, should interrogate the oncological community. A think tank of experts was created to delineate specificities and challenges stemming from trastuzumab biosimilars.

References

May 20, 2004·Journal of the National Cancer Institute·Mark D PegramDennis J Slamon
Oct 21, 2005·The New England Journal of Medicine·Martine J Piccart-GebhartUNKNOWN Herceptin Adjuvant (HERA) Trial Study Team
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Oct 14, 2011·The New England Journal of Medicine·Dennis SlamonUNKNOWN Breast Cancer International Research Group
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Citations

Aug 24, 2019·Future Oncology·Mark VerrillJavier Cortes
Nov 15, 2019·Expert Opinion on Therapeutic Patents·Leila VaniaStefan F T Weiss
Jun 22, 2018·Future Oncology·Xavier PivotElsa Curtit
Jul 14, 2018·British Journal of Cancer·Xavier Pivot, Thierry Petit

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