EMA approval for Zercepac, a trastuzumab biosimilar

Following a positive European Medicines Agency recommendation in May this year, the European Commission has now approved Shanghai Henlius Biotech (2696: HK) and Accord Healthcare Zercepac, a biosimilar of Roche’s Herceptin (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.

Henlius’s shares closed up 4.8% at HK$58.00 following the news.