Celltrion Receives European Approval for Aidenzelt, Biosimilar of Eylea

Expanding Ophthalmology Portfolio
Accelerating Entry into the 13 Trillion KRW Global Market

Celltrion has obtained marketing authorization from the European Commission for the Aflibercept biosimilar 'Idenselt'.

According to Celltrion on the 14th, Idenselt received approval for major indications including neovascular age-related macular degeneration, retinal vein occlusion macular edema, diabetic macular edema, and myopic choroidal neovascularization, which are covered by the original drug. The approved formulations are Idenselt injection and Idenselt prefilled syringe.

Previously, Celltrion confirmed the equivalence of CT-P42 compared to the original drug through a global Phase 3 clinical trial involving 348 patients with diabetic macular edema. Based on these results, Celltrion obtained approval from the Ministry of Food and Drug Safety in South Korea in May last year and is currently marketing the product.

The original product of Idenselt, Eylea, recorded sales of approximately 13 trillion KRW worldwide as of 2023. Following the launch of Idenselt in the domestic market last year and obtaining approval in Europe, Celltrion plans to accelerate its entry into major global markets both domestically and internationally.

Additionally, in December last year, Celltrion received a recommendation for marketing authorization approval from the Committee for Medicinal Products for Human Use (CHMP) under the European Medicines Agency for Idenselt as well as Actemra biosimilar Aptosma, and Prolia-Xgeva biosimilars Stoboclo-Osenbelt. It is expected that approvals for these products will be granted soon.

The CHMP’s recommendation for approval under the European Medicines Agency is known to influence the final approval by the European Commission. It is effectively interpreted as European drug approval, and Idenselt received final approval within about two months. Celltrion plans to expand its biosimilar portfolio into bone diseases and ophthalmic diseases following autoimmune diseases and anticancer drugs through the rapid approval of Idenselt and subsequent products.

A Celltrion official stated, "Through the marketing authorization of Idenselt, Celltrion has expanded its product portfolio in the European market and can accelerate its global market penetration. Given the prior approval recommendations for other subsequent products, we expect continuous approvals and will do our best to quickly launch products and strengthen market dominance."