Celltrion Applies for European Marketing Authorization of Aelia Biosimilar CT-P42

Celltrion announced on the 24th that it completed the marketing authorization application for the biosimilar of Aylea (active ingredient Aflibercept), 'CT-P42,' to the European Medicines Agency (EMA) on the 23rd (local time).

Celltrion applied for marketing authorization for Aylea's indications in Europe, including wet age-related macular degeneration, retinal vein occlusion macular edema, diabetic macular edema, and myopic choroidal neovascularization.

This authorization application was based on the global Phase 3 clinical trial results of CT-P42. Celltrion confirmed equivalence and similarity to the original drug through a Phase 3 clinical trial conducted on 348 patients with diabetic macular edema across 13 countries, including the Czech Republic, Hungary, Poland, and Spain.

The original drug of CT-P42, Aylea, recorded global sales of approximately $9.75699 billion (about 12.6841 trillion KRW) last year. The U.S. exclusivity for Aylea expires in May next year, and the European substance patent expires in November 2025.

A Celltrion official stated, "Based on the global Phase 3 clinical trial results of CT-P42, we have sequentially completed marketing authorization applications in major countries such as the U.S., Korea, and Europe, and are smoothly preparing to enter the global market. We will expand our product portfolio into various areas, including autoimmune diseases and anticancer treatments where we have existing strengths, as well as ophthalmic diseases, asthma, urticaria, and osteoporosis treatments, gradually strengthening our influence in the global market."

Celltrion plans to complete a portfolio of 11 products by 2025 by accelerating the development of new biosimilar pipelines in addition to the six products already launched: Remsima, Remsima SC (Zimpatra), Truxima, Herzuma, Vegzelma, and Uplima. Along with this, the company plans to complete the ongoing merger within the year and aims to achieve KRW 12 trillion in sales by 2030 through continuous new drug development and open innovation, aspiring to become a global big pharma.

This content was produced with the assistance of AI translation services.