Celltrion Applies for Domestic Approval of Aflibercept Biosimilar for Ophthalmic Treatment

Ailia Biosimilar 'CT-P42'
Approval Application Submitted Domestically Following the US

Celltrion announced on the 26th that it has completed the application for marketing authorization of the ophthalmic disease treatment drug 'Eylea (active ingredient Aflibercept)' biosimilar 'CT-P42' with the Ministry of Food and Drug Safety.

Incheon Songdo Celltrion Plant 2 exterior./Incheon=Photo by Hyunmin Kim kimhyun81@

Based on the global Phase 3 clinical trial results of CT-P42, Celltrion applied for domestic marketing authorization for all indications that Eylea holds in Korea, including wet age-related macular degeneration (wAMD) and diabetic macular edema (DME). Celltrion confirmed equivalence and similarity to the original drug in a Phase 3 clinical trial conducted on 348 patients with diabetic macular edema across 13 countries, including the Czech Republic, Hungary, Poland, and Spain.

Prior to this domestic approval application, Celltrion completed the approval application for CT-P42 with the U.S. Food and Drug Administration (FDA) last month. Following Korea, the company plans to sequentially apply for approval in major global countries such as Europe.

Celltrion expects that once CT-P42 obtains domestic approval, it will expand its portfolio to various diseases including ophthalmic diseases, following previously launched autoimmune disease treatments and anticancer drugs, thereby securing competitiveness not only in major global markets but also in the domestic market.

Eylea, developed by U.S. company Regeneron, is a blockbuster ophthalmic disease treatment drug that achieved global sales of $9.75699 billion (approximately 12.6841 trillion KRW) last year. The U.S. exclusivity for Eylea will expire in May 2024, and the European substance patent will expire in November 2025.

A Celltrion official stated, "We confirmed equivalence and similarity to the original drug in the global Phase 3 clinical trial of CT-P42 and completed the approval application with the Ministry of Food and Drug Safety. We will do our best to sequentially apply for approval in major countries including the U.S., Korea, and Europe, and to expand the biosimilar portfolio into the ophthalmic disease area."

Meanwhile, Celltrion plans to complete global approval applications for up to five biosimilars this year, including CT-P42. Earlier, in April and May respectively, it completed the European marketing authorization applications for the Zolair biosimilar 'CT-P39' and the Stelara biosimilar 'CT-P43'.

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