On 19 June 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 six biosimilars, including four aflibercept biosimilar medicines, an ustekinumab biosimilar, and a pegfilgrastim biosimilar.
The aflibercept biosimilars are: Mynzepli (aflibercept) by Advanz Pharma, and its duplicate Afiveg (aflibercept) by Stada Arzneimittel; and Vgenfli (aflibercept) and its duplicate Eiyzey (aflibercept), both by Zakłady Farmaceutyczne Polpharma, for the treatment of age-related macular degeneration and visual impairment.
Aflibercept is a vascular endothelial growth factor (VEGF) inhibitor. It is indicated for the treatment of neovascular (wet) age-related macular degeneration, macular oedema following retinal vein occlusion, diabetic macular oedema and diabetic retinopathy in patients with diabetic macular oedema [1].
The originator is Regeneron’s Eylea. The products will be available as a 40 mg/mL solution for injection in pre-filled syringes and vials.
Additionally, ELC Group’s Usymro ustekinumab biosimilar is intended for the treatment of Crohn’s disease, paediatric plaque psoriasis, psoriasis, and psoriatic arthritis. This product will be available as a 130 mg concentrate for solution for infusion, 45 mg solution for injection, and 45 mg and 90 mg solution for injection in pre-filled syringes.
Ustekinumab is a humanized monoclonal antibody that interferes with the triggering of the body’s inflammatory response through the suppression of certain cytokines. Specifically, it blocks interleukin IL 12 and IL 23 which help activate certain T cells. It binds to the p 40 subunit of both IL 12 and IL 23 so that they subsequently cannot bind to their receptors [2]. The originator is Johnson & Johnson’s Stelara.
And, also, Biosimilar Collaborations Ireland’s Vivlipeg pegfilgrastim, intended to reduce the duration of neutropenia and the incidence of febrile neutropenia after cytotoxic chemotherapy, is a biosimilar referencing Amgen’s Neulasta. 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 stimulates the production of white blood cells (neutrophils). Pegfilgrastim treatment is used to encourage bone marrow to produce more neutrophils to help fight infection in patients undergoing chemotherapy [3].
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References
1. GaBI Online - Generics and Biosimilars Initiative. Biosimilars of aflibercept [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2025 Jul 10]. Available from: www.gabionline.net/biosimilars/general/biosimilars-of-aflibercept
2. GaBI Online - Generics and Biosimilars Initiative. Biosimilars of ustekinumab [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2025 Jul 10]. Available from: www.gabionline.net/biosimilars/general/biosimilars-of-ustekinumab
3. GaBI Online - Generics and Biosimilars Initiative. Biosimilars of pegfilgrastim [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2025 Jul 10]. Available from: www.gabionline.net/biosimilars/general/Biosimilars-of-pegfilgrastim
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