Posted by Michael Wonder on 30 Jul 2020
Henlius and Accord Healthcare receive EMA approval for Zercepac, trastuzumab biosimilar
29 July 2020 - The European Commission has approved Shanghai Henlius Biotech and Accord Healthcare's Zercepac, a biosimilar trastuzumab, for the treatment of certain patients with HER2-positive early breast cancer, HER2-positive metastatic breast cancer and previously untreated HER2-positive metastatic gastric cancer.
The approval was based on a series of robust studies including comparative quality studies, preclinical and clinical studies. The results confirmed the biosimilarity of Zercepac, demonstrating comparable efficacy and safety to the reference product, Herceptin.
The approval of this medicine developed and manufactured by Henlius, is a significant milestone for both companies. Zercepac is the first monoclonal antibody, and third biosimilar, launched by Accord in Europe, and it is the first mAb developed by Henlius to be approved in the EU.
