Sandoz, the generics division of Novartis, announced on 12 February 2016 that it had acquired the rights for the development and commercialization of Pfizer’s biosimilar infliximab (PF-06438179) in the European Economic Area (EEA), which includes the 28 countries of the European Union (EU), plus Iceland, Liechtenstein and Norway.
Infliximab is a chimeric monoclonal antibody against tumour necrosis factor alpha (TNF-α). It is used to treat autoimmune diseases, such as ankylosing spondylitis, Crohn’s disease, psoriasis, psoriatic arthritis, rheumatoid arthritis and ulcerative colitis.
The news comes as part of Pfizer’s commitment to the European Commission (EC) in connection with the acquisition of Hospira to divest the clinical study programme, due to Hospira also having a biosimilar infliximab (Inflectra) [1]. Pfizer retains commercialization and manufacturing rights to biosimilar infliximab in all countries outside of the EEA.
Sandoz will complete the clinical study programme for PF-06438179, which includes a global phase III safety and efficacy trial of PF-06438179 in subjects with rheumatoid arthritis – the REFLECTIONS trial (B537-02). Sandoz will also submit the biosimilar infliximab to the European Medicines Agency for regulatory approval and registration with the EC.
Sandoz already has three biosimilars approved in the EU: 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 approved in the US. It has also submitted applications for approval of its etanercept (GP2015) and pegfilgrastim (LA-EP2006) biosimilars to the US Food and Drug Administration [4, 5].
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Reference
1. GaBI Online - Generics and Biosimilars Initiative. Biosimilars of infliximab [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2016 Mar 4]. Available from: www.gabionline.net/Biosimilars/General/Biosimilars-of-infliximab
2. GaBI Online - Generics and Biosimilars Initiative. Biosimilars approved in Europe [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2016 Mar 4] 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 Mar 4]. 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 Mar 4]. 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 Mar 4]. Available from: www.gabionline.net/Biosimilars/News/FDA-accepts-application-for-pegfilgrastim-biosimilar
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