Sandoz, the generics division of Novartis, announced on 8 April 2016 that the European Commission (EC) has approved a type II variation for the addition of a subcutaneous (SC) route of administration for its epoetin alfa biosimilar Binocrit’s nephrology (kidney function) indication.
Epoetin alfa is a human erythropoietin produced in cell culture using recombinant DNA technology. It stimulates erythropoiesis (increases red blood cell levels) and is used to treat anaemia, commonly associated with chronic renal failure and cancer chemotherapy.
The update of the summary of product characteristics (SmPC) in order to add an SC route of administration in addition to the intravenous route in the treatment of anaemia in patients with chronic renal failure was based on data from Sandoz’s SENSE clinical study (HX575-308). SENSE was an open label, single arm, multi-centre study that evaluated the safety and immunogenicity of HX575 epoetin alfa in the treatment of anaemia associated with chronic kidney disease in pre-dialysis and dialysis patients.
The decision, according to Sandoz’s Global Head Biopharmaceuticals, Ms Carol Lynch, will ‘mean more choice for healthcare professionals as well as increased convenience for patients’.
Sandoz is celebrating 10 years since it had its first biosimilar, Omnitrope (somatropin), approved in the European Union (EU) back in 2006 [1]. This was followed by two other biosimilar approvals in the EU: Binocrit (epoetin alfa) and Zarzio (filgrastim) [1]. The company also gained US approval for its filgrastim biosimilar, Zarxio (filgrastim-sndz), in March 2015 [2] – 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 the US Food and Drug Administration [3, 4].
Sandoz plans to make 10 regulatory filings over the three-year period 2015–2017 and reports that it has already submitted five.
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References
1. GaBI Online - Generics and Biosimilars Initiative. Biosimilars approved in Europe [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2016 Apr 22]. Available from: www.gabionline.net/Biosimilars/General/Biosimilars-approved-in-Europe
2. 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 Apr 22]. Available from: www.gabionline.net/Biosimilars/News/Zarxio-first-biosimilar-to-be-launched-in-US
3. GaBI Online - Generics and Biosimilars Initiative. FDA accepts application for etanercept biosimilar [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2016 Apr 22]. Available from: www.gabionline.net/Biosimilars/News/FDA-accepts-application-for-etanercept-biosimilar
4. GaBI Online - Generics and Biosimilars Initiative. FDA accepts application for pegfilgrastim biosimilar [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2016 Apr 22]. Available from: www.gabionline.net/Biosimilars/News/FDA-accepts-application-for-pegfilgrastim-biosimilar
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