EMA recommends approval for biosimilar pegfilgrastim Cavoley

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EMA recommends approval for biosimilar pegfilgrastim Cavoley

Biosimilares/Novedades | Posted 20/08/2026 0 Post your comment

On 23 July 2026, the European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion, recommending the granting of a marketing authorisation for Cavoley, a biosimilar pegfilgrastim developed by CuraTeQ Biologics, a subsidiary of Aurobindo Pharma.

Cavoley is a biosimilar medicinal product referencing Amgen's Neulasta (pegfilgrastim), which was authorised in the EU on 22 August 2002. The product will be available as a 6 mg solution for injection in pre-filled syringes.

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 [1].

The recommended indication for Cavoley is the reduction in the duration of neutropenia and the incidence of febrile neutropenia in adult patients treated with cytotoxic chemotherapy for malignancy, with the exception of chronic myeloid leukaemia and myelodysplastic syndromes. The product should be initiated and supervised by physicians experienced in oncology and/or haematology.

Data submitted to the EMA demonstrate that Cavoley has comparable quality, safety and efficacy to Neulasta (pegfilgrastim). The positive CHMP opinion is a significant milestone for CuraTeQ Biologics, which previously received EU approval for another pegfilgrastim biosimilar, Dyrupeg, in March 2025 [2].

The positive CHMP opinion for Cavoley follows just one month after Qilu Pharmaceuticals secured a similar opinion for its biosimilar Nylaspeg in June 2026 [3]. This brings the total number of pegfilgrastim biosimilars that have received positive opinions in Europe to 12, with 10 of these having been approved in the European Union since the first such approval—Accord Healthcare's Pelgraz in September 2018.

This continued interest in the pegfilgrastim biosimilar market, now more than seven years after the first such approval, underscores the sustained therapeutic value of this product class in oncology care.

The EU biosimilar regulatory framework marks its 20-year anniversary in 2026. Over the years, EMA's scientific experts have reviewed 180 biosimilars and issued positive opinions for 160 of these, demonstrating the EU's position as a global leader in biosimilar regulation.

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References
1. GaBI Online - Generics and Biosimilars Initiative. Biosimilars of pegfilgrastim [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2026 Aug 20]. Available from: www.gabionline.net/biosimilars/general/Biosimilars-of-pegfilgrastim
2. GaBI Online - Generics and Biosimilars Initiative. EC approves three biosimilars, 14 more await final authorization [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2026 Aug 20]. Available from: www.gabionline.net/biosimilars/news/ec-approves-three-biosimilars-14-more-await-final-authorization
3. GaBI Online - Generics and Biosimilars Initiative. EMA recommends approval for biosimilar Denosumab Ascend and pegfilgrastim Nylaspeg [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2026 Aug 20]. Available from: www.gabionline.net/biosimilars/news/ema-recommends-approval-for-biosimilar-denosumab-ascend-and-pegfilgrastim-nylaspeg

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