European Medicines Agency CHMP adopts positive opinions for two aflibercept biosimilars

The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) recommended two new ophthalmic medicines for approval at its January 2025 meeting. The two products, both manufactured by Amgen, are aflibercept biosimilars Pavblu and Skojoy. Both biosimilars are indicated for treatment of age-related macular degeneration (AMD), vision impairment due to macular oedema secondary to retinal vein occlusion and vision impairment due to myopic choroidal neovascularisation. Pavblu is also indicated for treatment of visual impairment due to diabetic macular oedema.^1-3

The CHMP recommended eight products for approval at its January meeting. Both ophthalmic biosimilars received positive opinions on 30 January. The reference product aflibercept (Eylea), developed by Bayer AG in conjunction with Regeneron, was authorised by the EMA in November 2012. Next, the European Commission will make a decision on marketing authorisation based on the opinion of the CHMP. According to documents from the EMA website, both Pavblu and Skojoy demonstrated “comparable quality, safety and efficacy to Eylea.”

Pavblu and Skojoy will be available as 40 mg/ml solution for injection, in both a pre-filled syringe and in a vial. Aflibercept is a recombinant fusion protein and anti-vascular endothelial growth factor, making this and similar drugs suitable therapies for multiple retinal pathologies.

In November 2024, the European Commission approved OPUVIZ (previously SB15) 40 mg/mL solution for injection in a vial, an aflibercept biosimilar from Samsung Bioepis.⁴ In December, the EMA issued a positive opinion and recommendation for marketing authorisation for Eydenzelt, an aflibercept biosimilar from Celltrion.⁵

References

1. Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 27-30 January 2025. European Medicine Agency. Published January 31, 2025. Accessed February 3, 2025. https://www.ema.europa.eu/en/news/meeting-highlights-committee-medicinal-products-human-use-chmp-27-30-january-2025

2. Pavblu [aflibercept]. Information page. European Medicine Agency. Updated January 31, 2025. Accessed February 3, 2025. https://www.ema.europa.eu/en/medicines/human/EPAR/pavblu

3. Skojoy [aflibercept]. Information page. European Medicine Agency. Updated January 31, 2025. Accessed February 3, 2025. https://www.ema.europa.eu/en/medicines/human/EPAR/skojoy

4. Crago S. European Commission approves aflibercept biosimilar OPUVIZ (previously SB15) from Samsung Bioepis. Ophthalmology Times Europe. Published November 20, 2024. Accessed February 3, 2025. https://europe.ophthalmologytimes.com/view/european-commission-approves-aflibercept-biosimilar-opuviz-previously-sb15-from-samsung-bioepis

5. Hayes H. EMA CHMP issues positive opinion for aflibercept biosimilar, two other candidates from Celltrion. Published December 16, 2024. Accessed February 3, 2025. https://europe.ophthalmologytimes.com/view/ema-chmp-issues-positive-opinion-for-aflibercept-biosimilar-two-other-candidates-from-celltrion-european-medicines-agency-eydenzelt-reference-eylea