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EMA approves pegfilgrastim biosimilars Fulphila, Pelmeg and Ziextenzo Posted 28/09/2018

The European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) announced on 21 September 2018 that it had recommended granting of marketing authorizations for the pegfilgrastim biosimilars Fulphila, Pelmeg and Ziextenzo.

The drugs are biosimilars of Amgen’s Neulasta (pegfilgrastim), which is a PEGylated form of the recombinant human granulocyte colony-stimulating factor (G-CSF) analogue filgrastim. Pegfilgrastim treatment can be used to stimulate bone marrow to produce more neutrophils (white blood cells) to fight infection in patients undergoing chemotherapy. The patents on Neulasta expired in the US in October 2015 and expired in Europe in August 2017 [1].

Fulphila (MYL-1401H) Mylan is produced by generics giant Mylan Pharmaceuticals (Mylan) and Indian biosimilars major Biocon. The companies submitted their application for approval of the pegfilgrastim biosimilar to EMA for approval back in July 2016 [2]. The application was delayed, however, after they were required to withdraw their application from EMA as part of ‘procedural requirements’ after implementation of corrective and preventive actions and re-inspection of Biocon’s ‘Drug Product facility’ in Bangalore were required before a good manufacturing practice (GMP) compliance certificate could be issued for the site [3].

EMA’s approval of Fulphila is based upon a review of evidence demonstrating biosimilarity. Data included similarity assessment in analytical testing, preclinical and clinical studies that demonstrated biosimilarity to the reference product, Neulasta. The phase I programme in healthy volunteers and phase III clinical study conducted in breast cancer patients receiving adjuvant and neoadjuvant chemotherapy demonstrated no clinically meaningful differences in terms of pharmacokinetics, pharmacodynamics, safety, efficacy and immunogenicity compared to Neulasta.

Pelmeg (B12019) is produced by Spanish biosimilars developer Cinfa Biotech. The company submitted its application for approval of the pegfilgrastim biosimilar to EMA for approval in October 2017 [4]. EMA’s approval of Pelmeg is based upon review of a comprehensive set of biosimilarity data from analytical, biofunctional and clinical studies comparing Pelmeg and Neulasta. The clinical development programme included two studies, which confirmed the analytical and biofunctional similarity of Pelmeg and Neulasta in highly sensitive clinical study settings.

Ziextenzo (LA-EP2006) is produced by Sandoz, the generics division of Novartis. The company submitted its application for approval of the pegfilgrastim biosimilar to EMA for approval in October 2017 [5]. EMA’s approval of Ziextenzo is based on comprehensive data confirming that the biosimilar pegfilgrastim matches the reference medicine in terms of safety, efficacy and quality.

EMA’s CHMP has recommended that Fulphila, Pelmeg and Ziextenzo be approved for the treatment of febrile neutropenia due to chemotherapy.

The CHMP’s opinion will now be reviewed by the European Commission (EC). The CHMP also gave a positive recommendation for two other pegfilgrastim biosimilars, Accord Healthcare’s Pelgraz and ERA Consulting’s Udenyca, in July 2018 [6]. Mylan/Biocon also received US Food and Drug Administration (FDA) for Fulphila in June 2018 [7].

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References
1.  Derbyshire M. Patent expiry dates for biologicals: 2017 update. Generics and Biosimilars Initiativ Journal (GaBI Journal). 2018;7(1):29-34. doi:10.5639/gabij.2018.0701.007
2.  GaBI Online - Generics and Biosimilars Initiative. Mylan and Biocon submit pegfilgrastim biosimilar to EMA [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2018 Sep 28]. Available from: www.gabionline.net/Biosimilars/News/Mylan-and-Biocon-submit-pegfilgrastim-biosimilar-to-EMA
3.  GaBI Online - Generics and Biosimilars Initiative. Biocon withdraws EU applications for trastuzumab and pegfilgrastim biosimilars [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2018 Sep 28]. Available from: www.gabionline.net/Biosimilars/General/Biocon-withdraws-EU-applications-for-trastuzumab-and-pegfilgrastim-biosimilars
4.  GaBI Online - Generics and Biosimilars Initiative. EMA accepts application for pegfilgrastim biosimilar from Cinfa [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2018 Sep 28]. Available from: www.gabionline.net/Biosimilars/News/EMA-accepts-application-for-pegfilgrastim-biosimilar-from-Cinfa
5.  GaBI Online - Generics and Biosimilars Initiative. EMA accepts biosimilar pegfilgrastim application from Sandoz [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2018 Sep 28]. Available from: www.gabionline.net/Biosimilars/News/EMA-accepts-biosimilar-pegfilgrastim-application-from-Sandoz
6.  GaBI Online - Generics and Biosimilars Initiative. Biosimilars approved in Europe [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2018 Sep 28]. Available from: www.gabionline.net/Biosimilars/General/Biosimilars-approved-in-Europe
7.  GaBI Online - Generics and Biosimilars Initiative. FDA approval for pegfilgrastim biosimilar Fulphila [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2018 Sep 28]. Available from: www.gabionline.net/Biosimilars/News/FDA-approval-for-pegfilgrastim-biosimilar-Fulphila

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Source: EMA, Cinfa Biotech, Mylan, Sandoz

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