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

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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 authorization 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 edema (DME), macular edema 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 authorization for the 3 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 authorization, 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