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Trastuzumab Biosimilar Approaches European Approval

Jason Harris
Published: Friday, Mar 23, 2018

Sean E. Harper, MD

Sean E. Harper, MD
The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion for the marketing authorization of ABP 980, a biosimilar to trastuzumab (Herceptin). 

Biosimilars are meant to foster competition and lower prices, and are defined as biological products that are "similar" or “interchangeable” with an FDA-licensed biological product, according to the US biosimilar pathway that was created under the Affordable Care Act.
von Minckwitz G, Ponomarova O, Morales S, et al. Efficacy and safety of biosimilar ABP 980 compared with trastuzumab in HER2-positive early breast cancer. In: Proceedings from the 2017 ESMO Congress; September 8-12, 2017; Madrid, Spain. Abstract 151PD.

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