FDA Approves Celltrion's Rituximab Biosimilar, Truxima

The FDA has approved Celltrion and Teva’s rituximab biosimilar, Truxima (rituximab-abbs). The biosimilar, referencing Rituxan, has been approved 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.

In a statement, FDA Commissioner Scott Gottlieb, MD, hailed approval of the drug as an example of the success of the agency’s Biosimilar Action Plan. “The Truxima approval is our third biosimilar approval in the past month. The growing pipeline of biosimilars is encouraging,” he said. “We’re seeing more biosimilar drugs gain market share as this industry matures. We’ll continue to make sure biosimilar medications are evaluated efficiently through a process that makes certain that these new medicines meet the FDA’s rigorous standards for approval.”

Truxima’s approval follows a unanimous recommendation of approval by the FDA’s Oncologic Drug Advisory Committee (ODAC) in October 2018. In a vote on whether the totality of the evidence supported the licensure of the biosimilar, all 16 committee members voted yes, for reasons some voters enumerated as “overwhelming biosimilarity and clinical trial evidence” that “really sealed the deal.”

The committee heard a review of data presented from various speakers, including advisory officials for the FDA who analyzed the drug’s data prior to the presentation. According to the FDA, although there were minor differences in clinically inactive compounds, the totality of the evidence suggested Truxima is highly similar to the reference product with no clinically meaningful differences.

Notably, while the reference rituximab also carries indications for inflammatory diseases including rheumatoid arthritis, Celltrion sought approval only for indications in oncology; when ODAC members asked about the reasoning behind only seeking an indication in NHL, a Celltrion representative stated that “We are only seeking approval in 3 [NHL] indications given the patent and exclusivity landscape at this time.”

Truxima, which is also approved and widely used in the European Union, is the 15th biosimilar, and the first rituximab biosimilar, approved by the FDA.