On December 16, Celltrion announced that it has received a positive opinion from the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) for Herzuma, its trastuzumab biosimilar. The CHMP has recommended that Herzuma be approved for the treatment of “early breast cancer, metastatic breast cancer, or metastatic gastric cancer whose tumors have either HER2 overexpression or HER2 gene amplification.” The opinion will be referred to the European Commission (EC) for a final decision on marketing authorization in the EU.
Celltrion recently launched Herzuma in South Korea. It also filed for marketing approval in Japan in April 2017 and filed a BLA with the FDA in July 2017.