China-based Shanghai Henlius Biotech Inc (2696.HK) and Accord Healthcare Limited, a subsidiary of Intas Pharmaceuticals Ltd, have received approval from the European Commission (EC) for their Zercepac, a biosimilar, trastuzumab, intended for the treatment of certain patients with HER2-positive early breast cancer, HER2-positive metastatic breast cancer and earlier untreated HER2-positive metastatic gastric cancer, it was reported on Wednesday.

The product received approval based on a series of studies including comparative quality studies, preclinical and clinical studies.

Zercepac was developed and produced by Henlius and is the first monoclonal antibody (mAb) and third biosimilar, launched by Accord in Europe, and is the first mAb developed by Henlius to be approved in the European Union.