FDA approves rituximab biosimilar Ruxience

Biosimilars/News | Posted 02/08/2019 post-comment0 Post your comment

US-based pharma giant Pfizer announced on 23 July 2019 that it had received approval from the US Food and Drug Administration (FDA) for its rituximab biosimilar (PF 05280586).

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Ruxience (rituximab pvvr) is a proposed biosimilar to Roche’s MabThera/Rituxan (rituximab), which had sales of CHF 7.3 billion (Euros 6.4 billion) in 2016, before the advent of biosimilars. The patents on MabThera/Rituxan expired in the US in September 2016 and in Europe in February 2013 [1].

Rituximab is a chimeric monoclonal antibody against the protein CD20, which is primarily found on the surface of immune system B cells. Rituximab destroys B cells and is therefore used to treat diseases that are characterized by excessive number of B cells, overactive B cells or dysfunctional B cells. This includes many lymphomas, leukaemias, transplant rejection and autoimmune disorders.

Ruxience has been approved for the treatment of adult patients with non-Hodgkin’s lymphoma (NHL), chronic lymphocytic leukaemia (CLL), granulomatosis with polyangiitis (GPA) and microscopic polyangiitis (MPA).

The FDA approval was based on the review of a comprehensive data package, which demonstrated biosimilarity of Ruxience to the reference product (MabThera/Rituxan). This included results from the REFLECTIONS B328-1006 clinical comparative study, which evaluated the efficacy, safety and immunogenicity, pharmacokinetics and pharmacodynamics of Ruxience and found no clinically meaningful differences in safety or efficacy compared to the reference product in patients with CD20-positive, low tumour burden follicular lymphoma [2].

Ruxience has been approved as a biosimilar, not as an interchangeable product. According to the Biologics Price Competition and Innovation Act of 2009 (BPCI Act), only a biological that has been approved as interchangeable may be substituted for the reference product without the intervention of the healthcare provider who prescribed the reference product.

The approval of Ruxience marks the seventh biosimilar from Pfizer (and its subsidiary Hospira) to be approved by FDA. Inflectra (infliximab-dyyb) was approved in April 2016, Ixifi (infliximab-qbtx) in December 2017, Retacrit (epoetin alfa-epbx) in May 2018, Nivestym (filgrastim-aafi) in July 2018, Trazimera (trastuzumab-qyyp) in March 2019 and Zirabev (bevacizumab-bvzr) in June 2019 [3].

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1. 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 
2. GaBI Online - Generics and Biosimilars Initiative. Positive phase III results for rituximab biosimilar PF 05280586 [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2019 Aug 2]. Available from: www.gabionline.net/Biosimilars/Research/Positive-phase-III-results-for-rituximab-biosimilar-PF-05280586 
3. GaBI Online - Generics and Biosimilars Initiative. Biosimilars approved in the US [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2019 Aug 2]. Available from: www.gabionline.net/Biosimilars/General/Biosimilars-approved-in-the-US 

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Source: Pfizer

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