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US FDA panel backs Celltrion, Teva's biosimilar of Roche's Rituxan for approval

Celltrion Inc. and Teva Pharmaceutical Industries Ltd said a U.S. Food and Drug Administration panel unanimously voted to recommend the approval of their biosimilar of Roche Holding AG's blood cancer drug Rituxan.

Biosimilars are intended to be lower-cost versions of biologic therapies — drugs derived from natural sources, such as microorganisms or plant or animal cells.

The U.S. FDA's Oncologic Drugs Advisory Committee voted 16-0 to back the Rituxan copycat CT-P10 for treating a non-aggressive form of B cell non-Hodgkin's lymphoma, or NHL, that has a high density of malignant cells expressing the CD20 protein.

B cell NHL starts in white blood cells called B lymphocytes and has a form called follicular lymphoma that grows slowly and responds well to treatment.

The companies' biosimilar to Rituxan, which works by targeting the CD20 protein, was recommended as a single agent to treat follicular B cell NHL when the disease has returned or is not responding to treatment and after chemotherapy when B-cell NHL is not progressing. It is also recommended as maintenance therapy in combination with chemotherapy for previously untreated follicular B-cell NHL and for patients who have seen a decline in their disease after a Rituxan and chemotherapy combination treatment.

CT-P10, if given green light by the agency, will be the first Rituxan biosimilar to gain U.S. approval for these three forms of treatment, said Celltrion CEO Woosung Kee.

The FDA will take into consideration the committee's recommendation before giving its final decision on the companies' biologics license application.

According to an Oct. 10 news release, the recommendation was based on the review of data that showed that there were no clinically meaningful differences between CT-P10 and Rituxan in safety and efficacy.

The agency's scientists had previously found no concerns in the data submitted to the FDA by Incheon, Korea-based Celltrion. The drug, being jointly commercialized by Celltrion and Israel-based Teva in the U.S. and Canada, has already gained approval in the European Union.

Roche reported $4.41 billion in 2017 sales for Rituxan in the U.S., where the drug is marketed in partnership with Biogen Inc.