Celltrion, Teva announce FDA acceptance of BLA for Herceptin biosimilar
Celltrion and Teva Pharmaceutical announced that the U.S. Food and Drug Administration has accepted for review the Biologics License Application for CT-P6, a proposed Monoclonal Antibody biosimilar to Herceptin, which is used for the treatment of Human Epidermal growth factor Receptor 2-overexpressing breast cancer and metastatic gastric cancer. The BLA for CT-P6 includes data for CT-P6 and reference trastuzumab in terms of efficacy, safety, immunogenicity, pharmacodynamics and pharmacokinetics. These trials were conducted in over 500 patients in 22 countries. CT-P6 has been approved by the Korean Ministry of Food and Drug Safety. Celltrion also filed marketing authorization applications for CT-P6 to the European Medicines Agency in October 2016. Celltrion and Teva entered into an exclusive partnership to commercialize CT-P6 and CT-P10 in the U.S. and Canada in October 2016.