European Medicines Agency CHMP adopts positive opinions for two aflibercept biosimilars

News
Article

Pavblu and Skojoy, both from Amgen, are indicated for the treatment of neovascular age-related macular degeneration

A gloved hand holding a syringe, superimposed over the European Union flag. Image credit: ©Savvapanf Photo – stock.adobe.com

According to the EMA, both Pavblu and Skojoy demonstrated comparable quality, safety and efficacy to Eylea. Image credit: ©Savvapanf Photo – stock.adobe.com

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

Newsletter

Join ophthalmologists across Europe—sign up for exclusive updates and innovations in surgical techniques and clinical care.

Recent Videos
Viha Vig, MBChB graduate student at the University of Auckland, New Zealand, discusses her poster presentation on the relationship between mitochondiral disease, Alzheimer disease, and other types of dementia.
Alfredo Sadun, MD, PhD, chief of Ophthalmology at the Doheny Eye Institute, University of California Los Angeles, shared exciting new research with the Eye Care Network during the Association for Research in Vision and Ophthalmology (ARVO) meeting on the subject of Leber hereditary optic neuropathy (LHON).
At this year's Association for Research in Vision and Ophthalmology (ARVO) meeting in Salt Lake City, Utah, Nitish Mehta, MD, shared highlights from his research documenting real-world results of aflibercept 8 mg for patients with diabetic macular oedema.
ARVO 2025: Anat Loewenstein, MD, shares data from herself and her colleagues on meeting needs of patients with diabetic retinopathy
At the American Society of Cataract and Refractive Surgeons annual meeting, Sheng Lim, MD, FRCOphth discusses the benefit of endoscopic cyclophotocoagulation for patients with primary open angle glaucoma and cataracts in the CONCEPT study
A photo of Seville, Spain, with the Congress on Controversies in Ophthalmology logo superimposed on it. Image credit: ©francovolpato – stock.adobe.com; logo courtesy COPHy
Anat Loewenstein, MD, Professor and Director, Department of Ophthalmology, Tel Aviv Medical Center, discusses the Congress on Controversies in Ophthalmology (COPHy)
3 experts are featured in this series.
Anat Loewenstein, MD, speaks about the 22nd Annual Angiogenesis, Exudation, and Degeneration Meeting in February 2025 and shares her global forecast for AI-driven home OCT
3 experts are featured in this series.
© 2025 MJH Life Sciences

All rights reserved.