FDA panel unanimously backs Celltrion's Rituxan biosimilar

Celltrion and its biosimilar marketing partner Teva may be on their way to challenging Roche’s top drug, Rituxan. On Wednesday, independent FDA advisers unanimously signed off on Celltrion’s Rituxan biosimilar, sending the drug to the FDA for a final say.

With a potential agency approval, Celltrion's biosim could challenge a Roche drug that brought in more than $4 billion in the U.S. last year. The FDA doesn't have to follow its panels' recommendations, but it typically does.

The 16-0 panel vote came after FDA advisers published a document early this week saying they found no "clinically meaningful differences … in terms of safety, purity and potency" between the biosim and Roche drug.

If approved, the biosimilar would be the first Rituxan copycat to secure a marketing nod in the U.S., Celltrion CEO Woosung Kee noted in a statement. Novartis is aiming for approval with its own biosim program, but suffered a setback at the FDA earlier this year.

Under a partnership, Teva is set to market Celltrion’s Rituxan biosimilar in the U.S. The company is "well positioned" to market the biosim, Brendan O’Grady said in a statement. Roche disclosed in an annual report that some of its Rituxan patent protections begin to expire this year.

The FDA previously rejected the Celltrion biosim after issuing a warning letter over manufacturing concerns at a plant in South Korea. Celltrion refiled for approval in May and said it expected to have approvals for the Rituxan biosim and for a Herceptin biosim by the end of the year. In refiling for approval, Celltrion said it "has made progress addressing the concerns ... and is committed to working with the agency to fully resolve all outstanding issues with the highest priority and urgency." 

Celltrion is only seeking approval for certain patients with non-Hodgkin's lymphoma; Rituxan boasts several other indications, including chronic lymphocytic leukemia and rheumatoid arthritis.

Along with Herceptin and Avastin, Rituxan is among a group of cancer drugs under biosimilar threat at cancer giant Roche. The trio generated more than $20 billion in sales last year.

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