First Rituximab Biosimilar, Truxima, Launches in the United States

Teva and Celltrion have announced the launch of their biosimilar rituximab, Truxima, in the United States. The product is being offered at a 10% discount to the list price of reference product, Rituxan. The product will begin to reach patients on November 11.

Truxima will be available at $845.55 for a 100-mg vial and $4227.75 for a 500-mg vial, though these costs do not take into account additional rebates or discounts that may apply.

“We are pleased to announce the launch of the first rituximab biosimilar, Truxima, with our marketing partner Teva in the US,” said Hyoung-Ki Kim, vice chairman at Celltrion Healthcare. “We believe that the introduction of Tuxima into the US market will contribute to addressing unmet needs of US patients as well.” Teva is also offering patient support services through its Comprehensive Oncology Reimbursement Expertise program.

Truxima was approved by the FDA in November of last year to treat adults with CD20-positive, B-cell non-Hodgkin lymphoma (NHL) either as monotherapy or in combination with chemotherapy. Like its reference product, Truxima has a label that carries a boxed warning alerting providers and patients to the risk of fatal infusion reactions, skin and mouth reactions, hepatitis B reactivation, and a rare but serious brain infection. The drug is also approved to treat chronic lymphocytic leukemia.

Notably, while the reference rituximab also carries indications for inflammatory diseases including rheumatoid arthritis, Celltrion sought approval only for indications in oncology; when members of the FDA's Oncologic Drugs Advisory Committee asked about the reasoning behind only seeking indications in cancer treatment, a Celltrion representative stated that “We are only seeking approval in 3 [oncology] indications given the patent and exclusivity landscape at this time.”

In light of a patent settlement with Genentech, however, Celltrion and Teva are now submitting an application to the FDA for the indications of rheumatoid arthritis, granulomatosis with polyangiitis, and microscopic polyangiitis.

News of the launch comes shortly after Pfizer, the license holder of the other FDA-approved rituximab biosimilar, Ruxience, announced that it plans to launch its product in the United States in January of 2020.