Celltrion And Teva Say FDA Accepts BLA For Proposed Biosimilar To Herceptin

(RTTNews) - Celltrion Inc. and Teva Pharmaceutical Industries Ltd. (TEVA) said that the U.S. Food and Drug Administration has accepted for review the Biologics License Application for CT-P6, a proposed Monoclonal Antibody (mAb) biosimilar to Herceptin (INN: trastuzumab) which is used for the treatment of Human Epidermal growth factor Receptor 2 (HER2)-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 (PD) and pharmacokinetics (PK). 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. FDA also accepted for review the Biologics License Application (BLA) for CT-P10, a proposed mAb biosimilar to Rituxan (rituximab) in June 2017.

The BLAs for both CT-P6 and CT-P10 have been accepted for filing by the FDA for standard review, with FDA Regulatory Action expected during the first half of 2018.