Celltrion, Teva Announce FDA Acceptance of BLA for Proposed Biosimilar to Herceptin

Celltrion and Teva Pharmaceutical Industries announced the U.S. Food and Drug Administration (FDA) has accepted for review the Biologics License Application (BLA) for CT-P6, a proposed Monoclonal Antibody (mAb) biosimilar to Herceptin which is used for the treatment of Human Epidermal growth factor Receptor 2 (HER2)-overexpressing breast cancer and metastatic gastric cancer.

"Following on the heels of our global success with Remsima®2 (Inflectra®3), our infliximab biosimilar, which has brought affordable and effective biologic treatment to many patients around the world with proven similarity of quality, efficacy and safety to the reference product, we are confident to submit a comprehensive package of quality, nonclinical and clinical data of CT-P6 for FDA review," said Woo Sung Kee, Chief Executive Officer of Celltrion. "If approved, CT-P6 will expand patient access to this important biosimilar treatment option in the U.S."

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.

"As Celltrion’s North American commercial partner for CT-P6 and CT-P10, a proposed mAb biosimilar to Rituxin®2 (rituximab), we look forward to the opportunity to leverage Teva’s strong legacy and U.S. commercial presence in Oncology to bring additional biosimilar treatment options to patients," said Paul Rittman, Senior Vice President and General Manager, Teva Oncology. "With today’s announcement, we are one-step closer to doing so in the U.S. We are very pleased to acknowledge the positive progress in our partnership with Celltrion to help provide these additional options, if approved, to patients living with cancer and other serious diseases."

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.