South Korean drugmaker Celltrion and Teva Pharmaceutical Industries Ltd (ADR) (NYSE:TEVA) have said that the Food and Drug Administration had accepted to review their biologics application for trastuzumub, a Herceptin biosimilar drug developed as a treatment for metastatic gastric cancer and breast cancer. The South Korean drugmaker intends to have trastuzumub sold in the United State through its retail partner.
“[W]e are confident to submit a comprehensive package of quality, nonclinical and clinical data of CT-P6 for FDA review. If approved, CT-P6 will expand patient access to this important biosimilar treatment option in the U.S.,” said Celltrion’s chief executive officer, Woo Sung Kee.
Biologics License Application
CT-P6’s Biologics License Application includes not just CT-P6 data but also information on pharmacokinetics, pharmacodynamics, immunogenicity, safety and efficacy. Trials for the biosimilar were done in 22 countries and in more than 500 patients. Already CT-P6 has received the approval of the Ministry of Food and Drug Safety in South Korea. Last year in October marketing authorization applications were filed with Europe Medicines Agency for CT-P6.
Teva, Celltrion’s commercial partner for CT-P10 and CT-P6 in the United States and Canada welcomed the move by the U.S. Food and Drug Administration. The general manager and senior vice president of Teva Oncology, Paul Rittman, added that this would be a benefit to patients since they would have more biosimilar treatment options available to them.
Celltrion and Teva first struck an exclusive partnership deal last year in October. FDA’s regulatory action is not expected until next year in the first half.
As a blockbuster drug, the sales of Herceptin have reached approximately $7.1 billion globally, with almost half of the sales being in the U.S. The drug which was originally made by Roche also intends to put up a fight for market share especially from copycat rivals. Some of the measures Roche has instituted to combat that include unveiling a subcutaneous formula which is believed to provide added convenience to patients. This is also expected to extend the life span of the original drug.
On Monday shares of Teva Pharmaceutical Industries fell by 0.53% to close the day at $32.17.