FDA approves first biosimilar to Rituxan

Ginestro

FDA approved the first biosimilar to rituximab (Rituxan, Genentech) to treat non-Hodgkin lymphoma.

Rituximab-abbs (Truxima, Celltrion) treats adult patients with CD20-positive, B-cell non-Hodgkin lymphoma (NHL) and is used as a single agent or in combination with chemotherapy.

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Truxima is the 15th biosimilar approved by FDA, and the agency is working to speed approval of biosimilars via its Biosimilars Action Plan.

“The Truxima approval is our third biosimiliar approval in the past month. The growing pipeline of biosimilars is encouraging. We’re seeing more biosimilar drugs gain market share as this industry matures,” said FDA Commissioner Scott Gottlieb, MD, in a statement from the agency.

The approval of Truxima opens up competition to Rituxan, “which should lower the price of the branded drug and offer an alternative to payers and patients,” Mark Ginestro, principal at KPMG Strategy, told FormularyWatch.

Biosimilars have generally been priced 15% to 30% below their brand counterparts, Ginestro added.

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However, Truxima has been approved as a biosimilar, not as an interchangeable product, a fact that can sometimes limit uptake of biosimilars by physicians, Ginestro pointed out.

FDA’s approval of Truxima is based on a review of evidence that included extensive structural and functional characterization, animal study data, human pharmacokinetic data, clinical immunogenicity data, and other clinical data that demonstrates Truxima is biosimilar to Rituxan, FDA said in the statement.

Like Rituxan, the labeling for Truxima contains a Boxed Warning to alert healthcare professionals and patients about increased risks of the following: fatal infusion reactions, severe skin and mouth reactions, some with fatal outcomes; Hepatitis B virus reactivation, that may cause serious liver problems including liver failure and death; and Progressive Multifocal Leukoencephalopathy, a rare, serious brain infection that can result in severe disability or death.

Read more: FDA backs new biosimilar, plus 2 more approvals