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FDA rejects Sandoz’s biosimilar pegfilgrastim application Posted 05/08/2016

Novartis disclosed on 19 July 2016 that the application by its Sandoz unit to market a biosimilar version of pegfilgrastim has been rejected by the US Food and Drug Administration (FDA).

Within its second quarter results, Novartis revealed that Sandoz had received a complete response letter from the agency – effectively rejecting the application. Novartis did not, however, provide any details about what concerns had prompted the letter. Although the company did state that they were ‘working with the agency to address remaining questions’.

Sandoz submitted its application for its proposed pegfilgrastim biosimilar (LA-EP2006) in November 2015, which included data from three pivotal clinical trials [1].

News of the rejection comes after the company gained a unanimous recommendation from the agency’s Arthritis Advisory Committee for FDA approval of its etanercept biosimilar (GP2015) [2].

Sandoz gained US approval for its filgrastim biosimilar, Zarxio (filgrastim-sndz), in March 2015 [3] and has also submitted an application for approval of its pegfilgrastim biosimilar (LA-EP2006) to the European Medicines Agency (EMA) [4]. Sandoz also has three biosimilars approved in the European Union: Binocrit (epoetin alfa), Omnitrope (somatropin) and Zarzio (filgrastim) [5].

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References
1. GaBI Online - Generics and Biosimilars Initiative. FDA accepts application for pegfilgrastim biosimilar [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2016 Aug 5]. Available from: www.gabionline.net/Biosimilars/News/FDA-accepts-application-for-pegfilgrastim-biosimilar
2. GaBI Online - Generics and Biosimilars Initiative. FDA advisors recommend approval of Sandoz’s etanercept biosimilar [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2016 Aug 5]. Available from: www.gabionline.net/Biosimilars/News/FDA-advisors-recommend-approval-of-Sandoz-s-etanercept-biosimilar
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 Aug 5]. Available from: www.gabionline.net/Biosimilars/News/Zarxio-first-biosimilar-to-be-launched-in-US
4. GaBI Online - Generics and Biosimilars Initiative. EMA accepts application for pegfilgrastim biosimilar [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2016 Aug 5]. Available from: www.gabionline.net/Biosimilars/News/EMA-accepts-application-for-pegfilgrastim-biosimilar
5. GaBI Online - Generics and Biosimilars Initiative. Biosimilars approved in Europe [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2016 Aug 5]. Available from: www.gabionline.net/Biosimilars/General/Biosimilars-approved-in-Europe

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Source: Novartis

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