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EC approval for pegfilgrastim biosimilars Pelmeg and Ziextenzo Posted 30/11/2018

In November 2018, pegfilgrastim biosimilars, Pelmeg and Ziextenzo, received European Commission (EC) approval.

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].

UK-based Mundipharma International (Mundipharma) and Spanish biosimilars developer Cinfa Biotech announced on 23 November 2018 that they had received EC approval for their pegfilgrastim biosimilar Pelmeg (B12019). Pelmeg was developed by Cinfa Biotech, which was acquired by Mundipharma in October 2018 [2].

The approval by the EC follows the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) positive recommendation on 21 September 2018. The EC’s approval is based on the CHMP recommendation, which concluded that the data provided on similarity assessments in analytical testing, as well as preclinical and clinical studies demonstrated biosimilarity to the reference product, Neulasta [3]. According to Mundipharma, Pelmeg demonstrated ‘in all cases’ … ‘comparable pharmacodynamics, pharmacokinetics, and immunogenicity to its reference product Neulasta’. The company added that ‘the information submitted, and conclusions reached, were comprehensive enough to extrapolate the indication for Neulasta across to Pelmeg. As such, it is indicated in the exact same way as subcutaneous (pre-filled syringe) Neulasta’.

Pelmeg is the fourth biosimilar to be commercialized by Mundipharma in Europe. The Mundipharma network of independent associated companies has distribution and marketing rights from Celltrion Healthcare for three other biosimilars – Remsima (infliximab) [4], Truxima and Herzuma.

Then on 27 November 2018, Sandoz, the generics division of Novartis, announced that its pegfilgrastim biosimilar Ziextenzo (LA‑EP2006) had also been approved by the EC.

The approval by the EC follows the positive recommendation by EMA’s CHMP on 21 September 2018. The EC’s approval is based on the CHMP recommendation, which concluded that the comprehensive data provided confirms that the biosimilar pegfilgrastim matches the reference medicine in terms of safety, efficacy and quality [3].

This latest approval for Sandoz brings the company’s total number of biosimilars approved in Europe to 11 [5]. 

Related article
Biosimilars of pegfilgrastim

References
1. Derbyshire M. Patent expiry dates for biologicals: 2017 update. Generics and Biosimilars Initiative Journal (GaBI Journal). 2018;7(1):29-34. doi:10.5639/gabij.2018.0701.007
2. GaBI Online - Generics and Biosimilars Initiative. Mundipharma buys Spanish biosimilars’ maker Cinfa Biotech [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2018 Nov 30]. Available from: www.gabionline.net/Pharma-News/Mundipharma-buys-Spanish-biosimilars-maker-Cinfa-Biotech
3. GaBI Online - Generics and Biosimilars Initiative. EMA approves pegfilgrastim biosimilars Fulphila, Pelmeg and Ziextenzo [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2018 Nov 30]. Available from: www.gabionline.net/Biosimilars/News/EMA-approves-pegfilgrastim-biosimilars-Fulphila-Pelmeg-and-Ziextenzo
4. GaBI Online - Generics and Biosimilars Initiative. Infliximab biosimilar to be distributed by Mundipharma [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2018 Nov 30]. Available from: www.gabionline.net/Biosimilars/News/Infliximab-biosimilar-to-be-distributed-by-Mundipharma
5. GaBI Online - Generics and Biosimilars Initiative. Biosimilars approved in Europe [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2018 Nov 30]. Available from: www.gabionline.net/Biosimilars/General/Biosimilars-approved-in-Europe

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Source: Mundipharma, Sandoz

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