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EC approval for rituximab biosimilar Ruxience Posted 24/04/2020

On 2 April 2020, pharma giant Pfizer announced that its rituximab biosimilar, Ruxience (PF‑05280586), had received European Commission (EC) approval.

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.

The approval by the EC on 1 April 2020 follows the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) positive recommendation on 31 January 2020 [1], which was based on a comprehensive data package demonstrating biosimilarity of Ruxience to the reference product (MabThera). The data included results from the REFLECTIONS B3281006 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 for the treatment of non-Hodgkin’s lymphoma (NHL), chronic lymphocytic leukaemia (CLL), rheumatoid arthritis (RA), granulomatosis with polyangiitis (GPA) and microscopic polyangiitis (MPA) and pemphigus vulgaris (PV).

Ruxience marks the seventh European approval for biosimilars from Pfizer (with its subsidiary Hospira). The company has also gained EC approval for Amsparity (adalimumab), Inflectra (rituximab), Nivestim (filgrastim), Retacrit (epoetin zeta), Trazimera (trastuzumab) and Zirabev (bevacizumab) [3].

Pfizer has received approval for Ruxience (rituximab-pvvr) from the US Food and Drug Administration [4].

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References
1. GaBI Online - Generics and Biosimilars Initiative. EMA approval for rituximab biosimilar Ruxience [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2020 Apr 24]. Available from: www.gabionline.net/Biosimilars/News/EMA-approval-for-rituximab-biosimilar-Ruxience
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 2020 Apr 24]. 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 Europe [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2020 Apr 24]. Available from: www.gabionline.net/Biosimilars/General/Biosimilars-approved-in-Europe
4. GaBI Online - Generics and Biosimilars Initiative. FDA approves rituximab biosimilar Ruxience [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2020 Apr 24]. Available from: www.gabionline.net/Biosimilars/News/FDA-approves-rituximab-biosimilar-Ruxience

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Source: Pfizer

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