Truxima (rituximab-abbs) is now available in the US for treatment of patients with non-Hodgkin’s lymphoma (NHL), chronic lymphocytic leukaemia (CLL), rheumatoid arthritis, granulomatosis with polyangiitis (Wegener’s granulomatosis) and microscopic polyangiitis.

The US Food and Drug Administration (FDA) approved Truxima, as the first rituximab biosimilar, back in November 2018 [1]. This delay between approval and launch again highlights the difficulty of bringing biosimilars to market in the US, despite the fact that the patents on the originator biological, Roche/Genentech’s MabThera/Rituxan expired in September 2016 [2].

FDA’s approval of Truxima was 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.

Earlier in 2020, the Centers for Medicare and Medicaid Services (CMS) granted pass-through status for Truxima in the hospital outpatient setting. The wholesale acquisition cost (WAC or list price) for Truxima will be 10% lower than Rituxan. Truxima is expected to be available through primary wholesalers at a WAC of US$845.55 per 100 mg vial and US$4,227.75 per 500 mg vial. Actual costs to individual patients and providers for Truxima are anticipated to be lower than WAC because WAC does not account for additional rebates and discounts that may apply. Savings on out-of-pocket costs may vary depending on the patient’s insurance payer and eligibility for participation in the assistance programme.

Importantly, Truxima is not indicated for the treatment of pemphigus vulgaris, a rare, serious, potentially life-threatening condition characterized by progressive painful blistering of the skin and mucous membranes. Genentech announced in June 2018 that it had received FDA approval for Rituxan for pemphigus vulgaris [1].

Celltrion and Teva entered into an exclusive partnership in October 2016 to commercialize Truxima in Canada and the US. They have also reached a settlement agreement with Genentech, including entry terms, although they say, ‘the terms and conditions of that agreement are confidential at this time’ [1].

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Biosimilars approved in the US

Biosimilars of rituximab

References
1. GaBI Online - Generics and Biosimilars Initiative. FDA approves first rituximab biosimilar Truxima [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2020 Jun 5]. Available from: www.gabionline.net/Biosimilars/News/FDA-approves-first-rituximab-biosimilar-Truxima
2. Derbyshire M. Patent expiry dates for biologicals: 2018 update. Generics and Biosimilars Initiative Journal (GaBI Journal). 2019;8(1):24-31. doi:10.5639/gabij.2019.0801.003

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