On July 30, 2020 Shanghai Henlius Biotech, Inc. (2696.HK) and Accord Healthcare Limited (Accord), reported that the European Commission (Zer) has 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 stomach cancer (Press release, Henlius Biopharmaceuticals, JUL 30, 2020, View Source [SID1234562532]). The approval was based on a number of robust studies, including comparative quality studies as well as preclinical and clinical studies. The results confirmed the biosimilarity of Zercepac and showed an efficacy and safety comparable to the reference product Herceptin.
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The approval of the drug developed and manufactured by Henlius is an important milestone for both companies. Zercepac is the first monoclonal antibody (mAb) and third biosimilar marketed by Accord in Europe, and it is the first mAb developed by Henlius to be approved in the EU.
Dr. Scott Liu , co-founder and CEO of Henlius , said: "Henlius mission is to improve the lives of patients by providing them with high quality and affordable protein therapeutics through technical innovation and operational excellence. Approval of Zercepac in the EU is a major milestone in our global strategy, and this achievement demonstrates that our biological development and manufacturing capabilities have reached international standards. In the future, Henlius will continue to offer high quality biologicals as new treatments that will benefit patients worldwide. "
Paul Tredwell , VP Specialty Brands of Accord, EMENA, said: "This product is an exciting addition to our growing oncology portfolio that provides patients across Europe with access to more than 30 high quality, affordable oncology treatments. With Zercepac, our first mAb, we have firmly anchored our competence in the market launch of complex medications in order to guarantee an improved patient access and to offer cost-effective alternatives to the overloaded health systems ".