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| Celltrion's biosimilar Truxima |
Given that the committee recommends a biosimilar a few months before the FDA gives an actual license for the U.S. market, Truxima is believed to be close to receiving the final go ahead.
The FDA's Oncologic Drugs Advisory Committee (ODAC) voted unanimously 16-0 to recommend approval of Truxima for use in the U.S., according to the firm. Truxima, or CT-P10, is a proposed monoclonal antibody biosimilar to Rituxan, developed by Roche Holding.
Truxima is used to treat non-Hodgkin's lymphoma, a type of blood cancer, chronic lymphocytic leukemia and rheumatoid arthritis.
Celltrion said it expects the FDA may approve the biosimilar between November and December.
Before approving Celltrion's Remsima, a biosimilar for autoimmune diseases, the FDA held an advisory committee to recommend the approval in February 2016 and approved it two months later.
Celltrion said the committee based its recommendation on the clinical development program for Truxima showing there were "no clinically meaningful differences between Truxima and Rituxan in terms of the safety, purity and potency of the product for the three proposed indications."
"We welcome the ODAC's recommendation. If approved by the FDA, Truxima will be the first Rituxan biosimilar to be approved in the U.S. for the proposed uses," Celltrion CEO Kee Woo-sung said in an English statement. "The development of biosimilars is of great importance in the field of oncology, and has the potential to increase accessibility to treatments for the patients."
Truxima has been under FDA review since June following the resubmission of its application for marketing approval in May, when its first attempt failed due to production facility and manufacturing process issues.
Should the FDA approve Truxima, Celltrion will become the first company to distribute a Rituxan-biosimilar in the U.S., which industry officials say is critical given the huge first-mover advantage in the market.
The market of Rituxan in the U.S. is assumed to be valued at 5 trillion won ($4.37 billion), accounting for more than 50 percent of the global Rituxan market.
Truxima was approved by European Medicines Agency in February 2017 and began being sold in the U.K. two months later.
