On 30 January 2025, the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) adopted positive opinions, recommending the granting of a marketing authorization for for three biosimilar medicines: Dyrupeg (pegfilgrastim), Pavblu (aflibercept) and its duplicate Skojoy (aflibercept).
Pavblu and Skojoy
Amgen’s Pavblu and Skojoy are biosimilars referencing Regeneron and Bayer’s Eylea (aflibercept).
Both Pavblu and Skojoy are indicated for:
- neovascular (wet) age-related macular degeneration (AMD)
- visual impairment due to macular oedema secondary to retinal vein occlusion
- visual impairment due to myopic choroidal neovascularisation
and Pavblu is also indicated for:
- visual impairment due to diabetic macular oedema
Pavblu and Skojoy will be available as 40 mg/mL solutions for injection in pre-filled syringe and vial.
Amgen’s Pavblu was the first aflibercept biosimilar to be launched in the US in October 2024 [1].
There are four aflibercept biosimilars already approved by the European Commission (EC) but not yet launched in the EU: Biocon’s Yesafili (September 2023), Sandoz’s Afqlir (November 2024), Samsung Bioepis/Biogen’s Opuviz (SB15) (November 2024) and Formycon/Klinge’s FYB203/Baiama/Ahzantive (January 2025) [2].
On 12 December 2024, an aflibercept biosimilar, Celltrion’s Eydenzelt/CT-P42, received a positive opinion during the EMA’s CHMP meeting, pending EC approval. This brings the total number of aflibercept biosimilars approved in Europe to seven.
Additionally, Alvotech/Advanz Pharma and Altos Biologics (a subsidiary of South Korea’s Alteogen) submitted Marketing Authorization Applications to the EMA for aflibercept biosimilars on 15 August 2024 and 1 July 2024. If approved, this could increase the total number of aflibercept biosimilars in Europe to nine.
Dyrupeg
CuraTeQ Biologics’ (CuraTeQ) Dyrupeg is a biosimilar referencing Amgen’s Neulasta (pegfilgrastim). CuraTeQ is a wholly owned subsidiary of Aurobindo Pharma Ltd.
Dyrupeg is approved for neutropenia and will be available as a 6 mg solution for injection in pre-filled syringe.
The positive CHMP opinion for Dyrupeg was supported by data show that it has comparable quality, safety and efficacy to Neulasta.
This comes over six years after the approval of the first European pegfilgrastim biosimilar, Accord Healthcare’s Pelgraz, in September 2018.
Additionally, the filgrastim biosimilar Zefylti (BP13) is CuraTeQ’s first biosimilar to receive a positive opinion from the EMA’s CHMP on 12 December 2024 [3]. CuraTeQ has a pipeline of 14 biosimilars, primarily targeting the immunology and oncology segments.
Related articles
FDA approves third aflibercept biosimilar Ahzantive
EC approval of natalizumab, aflibercept and tocilizumab biosimilars
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References
1. GaBI Online - Generics and Biosimilars Initiative. FDA approves aflibercept biosimilars Enzeevu and Pavblu [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2025 Feb 25]. Available from: www.gabionline.net/biosimilars/news/fda-approves-aflibercept-biosimilars-enzeevu-and-pavblu
2. GaBI Online - Generics and Biosimilars Initiative. EC approves eight biosimilars, eight more await final authorization [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2025 Feb 25]. Available from: www.gabionline.net/biosimilars/news/ec-approves-eight-biosimilars-eight-more-await-final-authorization
3. GaBI Online - Generics and Biosimilars Initiative. EMA recommends approval for tocilizumab biosimilar Avtozma and filgrastim biosimilar Zefylti [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2025 Feb 25]. Available from: www.gabionline.net/biosimilars/news/ema-recommends-approval-for-tocilizumab-biosimilar-avtozma-and-filgrastim-biosimilar-zefylti
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