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Rituximab biosimilar from Sandoz accepted for review by EMA Posted 10/06/2016

Sandoz, the generics division of Novartis, announced on 24 May 2016 that its regulatory submission for its proposed rituximab biosimilar (GP2013) had been accepted by the European Medicines Agency (EMA).

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, making it a lucrative target for biosimilars manufacturers. The patents on MabThera/Rituxan expire in the US in September 2016 and expired in Europe in February 2013 [1].

Sandoz is seeking approval for its biosimilar in the same indications as the reference product (MabThera). In addition to analytical, functional and preclinical data, the submission includes data from two pivotal confirmatory safety, pharmacokinetic/pharmacodynamic and efficacy studies that involved 629 follicular lymphoma and 173 rheumatoid arthritis patients.

Sandoz already has three biosimilars approved in the European Union: Binocrit (epoetin alfa), Omnitrope (somatropin) and Zarzio (filgrastim) [2]. The company also gained US approval for its filgrastim biosimilar, Zarxio (filgrastim-sndz), in March 2015 [3] – the first biosimilar to be approved in the US. It has also submitted applications for approval of its etanercept (GP2015) and pegfilgrastim (LA-EP2006) biosimilars to both the US Food and Drug Administration [4, 5] and EMA [6, 7].

The submission of rituximab biosimilar marks the sixth of 10 regulatory filings the company plans to make over the three-year period from 2015 to 2017.

Related article
Biosimilars of rituximab

References
1. Derbyshire M. Patent expiry dates for best-selling biologicals. Generics and Biosimilars Initiative Journal (GaBI Journal). 2015;4(4):178-9. doi:10.5639/gabij.2015.0404.040
2. GaBI Online - Generics and Biosimilars Initiative. Biosimilars approved in Europe [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2016 Jun 10]. Available from: www.gabionline.net/Biosimilars/General/Biosimilars-approved-in-Europe
3. GaBI Online - Generics and Biosimilars Initiative. Zarxio first biosimilar to be launched in US [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2016 Jun 10]. Available from: www.gabionline.net/Biosimilars/News/Zarxio-first-biosimilar-to-be-launched-in-US
4. GaBI Online - Generics and Biosimilars Initiative. FDA accepts application for etanercept biosimilar [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2016 Jun 10]. Available from: www.gabionline.net/Biosimilars/News/FDA-accepts-application-for-etanercept-biosimilar
5. GaBI Online - Generics and Biosimilars Initiative. FDA accepts application for pegfilgrastim biosimilar [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2016 Jun 10]. Available from: www.gabionline.net/Biosimilars/News/FDA-accepts-application-for-pegfilgrastim-biosimilar
6. GaBI Online - Generics and Biosimilars Initiative. EMA accepts application for etanercept biosimilar biosimilar [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2016 Jun 10]. Available from: www.gabionline.net/Biosimilars/News/EMA-accepts-application-for-etanercept-biosimilar
7. GaBI Online - Generics and Biosimilars Initiative. EMA accepts application for pegfilgrastim biosimilar [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2016 Jun 10]. Available from: www.gabionline.net/Biosimilars/News/EMA-accepts-application-for-pegfilgrastim-biosimilar

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Source: Sandoz

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