Posted by Michael Wonder on 31 Jul 2017
Celltrion and Teva announce U.S. FDA acceptance of biologics license application for proposed biosimilar to Herceptin (trastuzumab)
31 July 2017 - Celltrion and Teva Pharmaceuticals today announced that the U.S. FDA has accepted for review the biologics license application for CT-P6, a proposed monoclonal antibody biosimilar to Herceptin (trastuzumab) which is used for the treatment of human epidermal growth factor receptor 2 over-expressing breast cancer and metastatic gastric cancer.
The application 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.
