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EC approval for pegfilgrastim biosimilar Fulphila Posted 22/02/2019

In January 2019, the pegfilgrastim biosimilar, Fulphila, received European Commission (EC) approval.

The product is a biosimilar 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].

India-based Biocon and US-based drugmaker Mylan announced on 30 November 2018 that they had received EC approval for their pegfilgrastim biosimilar Fulphila (MYL 1401H).

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 was 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 [2].

At its meeting of the EMA’s Committee for Medicinal Products for Human Use (CHMP) held on 28-31 January 2019, the agency also announced that the applications for pegfilgrastim biosimilars Cavoley from Stada Arzneimittel and Efgratin from Gedeon Richter had been withdrawn.

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Biosimilars of pegfilgrastim

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. EMA approves pegfilgrastim biosimilars Fulphila, Pelmeg and Ziextenzo [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2019 Jan 31]. Available from: www.gabionline.net/Biosimilars/News/EMA-approves-pegfilgrastim-biosimilars-Fulphila-Pelmeg-and-Ziextenzo

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Source: Biocon, EMA

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