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EMA accepts biosimilar pegfilgrastim application from Sandoz Posted 03/11/2017

Sandoz, the generics division of Novartis, announced on 27 October 2017 that the regulatory submission for its proposed pegfilgrastim biosimilar (LA-EP2006) had been accepted by the European Medicines Agency (EMA).

Pegfilgrastim is a PEGylated form of the recombinant human granulocyte colony-stimulating factor (G-CSF) analogue filgrastim. It serves to stimulate the level of white blood cells (neutrophils). Pegfilgrastim treatment can be used to stimulate bone marrow to produce more neutrophils (white blood cells) to fight infection in patients undergoing chemotherapy.

Sandoz first applied for European Union (EU) approval for its proposed pegfilgrastim biosimilar (Zioxtenzo) back in February 2016 [1]. However, it withdrew the application in January 2017 after EMA expressed doubts about its biosimilarity and manufacturing [2].

Sandoz says that this time ‘the comprehensive data package, submitted as part of the Marketing Authorization Application, includes analytical, preclinical and clinical data and strongly demonstrates that the biosimilar pegfilgrastim matches the reference medicine in terms of safety, efficacy and quality’.

The biosimilar application for LA-EP2006 includes data from phase I pharmacokinetic and pharmacodynamic studies in healthy volunteers, as well as phase III confirmatory safety and efficacy studies in breast cancer patients.

Sandoz is still leading the way when it comes to biosimilars. The company already has five biosimilars approved in the EU [3] and two in the US [4]. The company also has three biosimilars currently under EMA review: adalimumab (GP2017) [5], infliximab (PF-06438179) [6] and pegfilgrastim (LA-EP2006).

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Adalimumab and infliximab biosimilars from Sandoz accepted for review by EMA

References
1. GaBI Online - Generics and Biosimilars Initiative. EMA accepts application for pegfilgrastim biosimilar [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2017 Nov 3]. Available from: www.gabionline.net/Biosimilars/News/EMA-accepts-application-for-pegfilgrastim-biosimilar
2. GaBI Online - Generics and Biosimilars Initiative. Sandoz withdraws biosimilar pegfilgrastim application [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2017 Nov 3]. Available from: www.gabionline.net/Biosimilars/News/Sandoz-withdraws-biosimilar-pegfilgrastim-application
3. GaBI Online - Generics and Biosimilars Initiative. Biosimilars approved in Europe [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2017 Nov 3]. Available from: www.gabionline.net/Biosimilars/General/Biosimilars-approved-in-Europe
4. GaBI Online - Generics and Biosimilars Initiative. Biosimilars approved in the US [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2017 Nov 3]. Available from: www.gabionline.net/Biosimilars/General/Biosimilars-approved-in-the-US
5. GaBI Online - Generics and Biosimilars Initiative. Adalimumab and infliximab biosimilars from Sandoz accepted for review by EMA [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2017 Nov 3]. Available from: www.gabionline.net/Biosimilars/News/Adalimumab-and-infliximab-biosimilars-from-Sandoz-accepted-for-review-by-EMA
6. GaBI Online - Generics and Biosimilars Initiative. Infliximab biosimilar to be distributed by Mundipharma [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2017 Nov 3]. Available from: www.gabionline.net/Biosimilars/News/Infliximab-biosimilar-to-be-distributed-by-Mundipharma

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Source: Sandoz

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