FDA Accepts Application for Teva’s Herceptin Biosimilar

On July 31, 2017, Teva Pharmaceutical Industries and its partner, Celltrion, announced that FDA has accepted for review the biologics license application (BLA) for CT-P6, a proposed monoclonal antibody (mAb) biosimilar to Roche’s Herceptin (trastuzumab), which is indicated for treating human epidermal growth factor receptor 2 (HER2)-overexpressing breast cancer and metastatic gastric cancer. Herceptin is among Roche’s top-five selling therapies with 2016 sales of CHF 6.78 billion (US$7.03 billion). CT-P6 has been approved by the Korean Ministry of Food and Drug Safety, and Celltrion also filed marketing authorization applications with the European Medicines Agency in October 2016.

FDA’s decision follows an earlier June 2017 decision in which the agency also accepted for review the BLA for CT-P10, Celltrion and Teva’s proposed mAb biosimilar to Roche’s Rituxan (rituximab), which is indicated for treating non-Hodgkin’s lymphoma, chronic lymphocytic leukemia, rheumatoid arthritis, and granulomatosis with polyangiitis and microscopic polyangiitis. Rituxan is Roche’s top-selling therapy with 2016 sales of CHF 7.3 billion (US$7.56 billion).

Celltrion and Teva entered into an exclusive partnership in October 2016 to commercialize CT-P6 and CT-P10 in the United States and Canada. The BLAs for CT-P6 and CT-P10 were accepted for filing under standard review. FDA regulatory action is expected during the first half of 2018.