EMA CHMP issues positive opinion for aflibercept biosimilar, two other candidates from Celltrion

News
Article

The European Commission will assess the marketing authorisation for Eydenzelt (reference product Eylea)

Gloved hands fill a syringe in front of the European Union flag. Image credit: ©BillionPhotos.com – stock.adobe.com

Next, the European Commission will rule whether to issue marketing authorisations for the three Celltrion biosimilars. Image credit: ©BillionPhotos.com – stock.adobe.com

The European Medicines Agency (EMA) Committee for Medicinal Products for Human Use (CHMP) announced opinions for three biosimilar candidates from Celltrion, including a biosimilar for reference product aflibercept (Eylea). The EMA issued a positive opinion and recommendation for marketing authorisation for Eydenzelt (biosimilar aflibercept).

According to a press release, Celltrion, a biopharmaceutical company based in South Korea, also received positive opinions for Stoboclo and Osenvelt (biosimilar denosumab, used in treating osteoporosis and hypercalcemia) and Avtozma (biosimilar tocilizumab, used in treating moderate to severe rheumatoid arthritis).1

Eydenzelt, previously known as CT-P42, is a 40 mg/mL solution for injection available in a vial and as a prefilled syringe. The aflibercept biosimilar is recommended for approval to treat multiple retinal disorders: neovascular (wet) age-related macular degeneration (AMD), diabetic macular oedema (DMO), macular oedema following retinal vein occlusion (branch RVO or central RVO) and myopic choroidal neovascularisation (myopic CNV). In a Phase III study, the efficacy, safety, pharmacokinetics and immunogenicity of Eydenzelt were compared to the reference product aflibercept in patients with DMO. The product met predefined equivalence criteria.

The European Commission will rule whether to issue marketing authorisation for the three Celltrion biosimilars. Eyedenzelt is one of several aflibercept biosimilars to receive a positive regulatory update in 2024. Earlier this year, Afqlir (Sandoz Group) received a marketing authorisation, as did FYB203 (Formycon AG and Klinge Biopharma GmbH), and OPUVIZ (Samsung Bioepis) received European Commission approval.

Taehun Ha, vice president of Celltrion and head of the European business unit, said the approvals demonstrate the company’s value in its extensive antibody biosimilar portfolio. “These approvals underscore our commitment to supporting European healthcare systems by improving access to high-quality, affordable treatments,” he said. “Our focus remains on empowering clinicians with the tools and solutions they need, as we aim to transition from a pioneer to a frontier leader in European healthcare.”

Reference
  1. Celltrion Receives Positive CHMP Opinion for Three Biosimilars in the European Union. Press release. Celltrion. Published 16 December, 2024. Accessed 16 December, 2024. https://www.celltrion.com/en-us/company/media-center/press-release/3620

Newsletter

Get the essential updates shaping the future of pharma manufacturing and compliance—subscribe today to Pharmaceutical Technology and never miss a breakthrough.

Recent Videos
João Pedro Marques, MD, MSc, PhD discusses a retrospective study of 800 patients with inherited retinal diseases during the American Society of Retina Specialists (ASRS) annual meeting
Christine Curcio, PhD, of the University of Alabama at Birmingham Heersink School of Medicine, shares histology update and revised nomenclature for OCT with Sheryl Stevenson of the Eye Care Network and Ophthalmology Times
SriniVas R. Sadda, MD, FARVO, shares key points from his retina presentation at the International SPECTRALIS Symposium
© 2025 MJH Life Sciences

All rights reserved.