EMA approval for rituximab biosimilar Ruxience Posted 07/02/2020

The European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) announced on 31 January 2020 that it had recommended granting marketing authorization for the rituximab biosimilar Ruxience.

Ruxience (PF-05280586) is produced by Pfizer. The positive CHMP opinion follows the reporting of positive results phase III results for PF‑05280586 at the American Society of Hematology Meeting (ASH) annual meeting in December 2018 [1].

The product is a proposed biosimilar to Roche’s MabThera/Rituxan (rituximab), which had worldwide 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 [2].

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 CHMP has recommended that Ruxience be approved for the treatment of non-Hodgkin’s lymphoma, chronic lymphocytic leukaemia, rheumatoid arthritis, granulomatosis with polyangiitis and microscopic polyangiitis and pemphigus vulgaris.

The CHMP positive opinion is based on a comprehensive data package which demonstrates biosimilarity of Ruxience to the reference product. This includes 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 [1].

Pfizer (with its subsidiary Hospira) already has five biosimilars approved in the EU: Inflectra (rituximab), Nivestim (filgrastim), Retacrit (epoetin zeta), Trazimera (trastuzumab) and Zirabev (bevacizumab) [3].

Pfizer has also 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. Positive phase III results for rituximab biosimilar PF 05280586 [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2020 Feb 7]. Available from: www.gabionline.net/Biosimilars/Research/Positive-phase-III-results-for-rituximab-biosimilar-PF-05280586
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
3. GaBI Online - Generics and Biosimilars Initiative. Biosimilars approved in Europe [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2020 Feb 7]. 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 Feb 7]. Available from: www.gabionline.net/Biosimilars/News/FDA-approves-rituximab-biosimilar-Ruxience

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Source: EMA, Pfizer

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