FDA accepts application for rituximab biosimilar from Sandoz

Biosimilars/News | Posted 29/09/2017 post-comment0 Post your comment

Sandoz, the generics division of Novartis, announced on 12 September 2017 that the regulatory submission for its proposed rituximab biosimilar (GP2013) had been accepted by the US Food and Drug Administration (FDA).

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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 product is a proposed biosimilar to Roche’s MabThera/Rituxan (rituximab), which had worldwide sales of CHF 7.05 billion (Euros 6.38 billion) in 2015. The patents on MabThera/Rituxan expired in the US in September 2016 and expired in Europe in February 2013 [1].

The biosimilar application for GP2013 includes data from a pharmacokinetic/pharmacodynamic (PK/PD) trial in rheumatoid arthritis (ASSIST‑RA), and a phase III confirmatory safety and efficacy study in follicular lymphoma (ASSIST-FL) [2].

Sandoz says that it ‘believes these data provide confirmation that the proposed biosimilar matches the reference medicine in terms of safety, efficacy and quality’. Its rituximab biosimilar GP2013 (Rixathon) was approved by the European Commission in June 2017 [3]. Including biosimilar rituximab, the company says that it plans ‘to launch a total of five major oncology and immunology biosimilars between 2017 and 2020’.

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1. Derbyshire M. Patent expiry dates for biologicals: 2016 update. Generics and Biosimilars Initiative Journal (GaBI Journal). 2017;6(1):27-30. doi:10.5639/gabij.2017.0601.006
2. GaBI Online - Generics and Biosimilars Initiative. EC approval for rituximab biosimilar Rixathon [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2017 Sep 29]. Available from: www.gabionline.net/Biosimilars/News/EC-approval-for-rituximab-biosimilar-Rixathon
3. GaBI Online - Generics and Biosimilars Initiative. Biosimilars approved in Europe [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2017 Sep 29]. Available from: www.gabionline.net/Biosimilars/General/Biosimilars-approved-in-Europe

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Source: Sandoz

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