Trastuzumab Biosimilar Approaches European Approval

March 23, 2018 – 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. If the European Commission now follows the CHMP recommendation, ABP 980 would be approved in in the European Union, Norway, Iceland, and Liechtenstein as a treatment for patients with HER2-positive metastatic breast cancer, HER2-positive … (leggi tutto)