Tuesday, 16 Jul 2019

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FDA Approves Biosimilar Rituximab for NHL, not RA

The U.S. Food and Drug Administration on Wednesday approved Celltrion biosimilar of rituximab called Truxima; previously called CT-P10, now generically labeled as rituximab-abbs.  This is the first biosimilar to the Rituxan currently approved to treat non-Hodgkin’s lymphoma.  Truxima is not approved for use in rheumatoid arthritis, vasculitis, pemphigus vulgaris or chronic lymphocytic leukemia. See package insert here.

The approval was largely expected as the drug won unanimous backing from an FDA advisory panel in October 2018, which deemed it highly similar to Rituxan.  Biosimilarity was clinically established in trials of lymphoma patients and not in other clinical populations (eg, RA, GPA, etc).

Truxima’s label comes with the same boxed warning as Rituxan, noting fatal infusion reactions, hepatitis B reactivation, severe mucocutaneous reactions and progressive multifocal leukoencephalopathy (PML). 

Roche’s drug, approved in 1997, is marketed as Rituxan in the United States, Japan and Canada and as MabThera elsewhere.

Earlier this month, Novartis International AG said it would no longer pursue U.S. regulatory approval for its biosimilar of Rituxan after the FDA sought additional information to support the company’s application for the drug.

Celltrion entered into a partnership with Teva Pharmaceutical Industries in 2016 to commercialize Truxima in United States and Canada.

Disclosures: 
The author has received compensation as an advisor or consultant on this subject

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