Celltrion Applies for US Approval of Eylea Biosimilar... Targeting $12 Trillion Market

Application for All Original Indications for Adults
Aflibercept Biosimilar 'CT-P42'

Celltrion announced on the 30th that it submitted a new drug application to the U.S. Food and Drug Administration (FDA) for 'CT-P42,' a biosimilar of the ophthalmic disease treatment 'Eylea' (active ingredient Aflibercept), on the 29th (local time).

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

Based on the global Phase 3 clinical trial results of CT-P42, Celltrion applied for approval for all indications held by Eylea in the U.S., excluding pediatric indications such as wet age-related macular degeneration (wAMD) and diabetic macular edema (DME). Following the U.S. application, Celltrion plans to sequentially apply for CT-P42 approval in major global markets including Europe.

In the Phase 3 clinical trial conducted in 13 countries including the Czech Republic, Hungary, Poland, and Spain, involving 348 patients with diabetic macular edema, Celltrion confirmed equivalence and similarity compared to the original drug.

Eylea, developed by U.S.-based Regeneron, is a blockbuster ophthalmic disease treatment that achieved global sales of $9.75699 billion (approximately KRW 12.6841 trillion) last year. The U.S. exclusivity for Eylea is set to 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 Phase 3 clinical trial of CT-P42 and have completed the new drug application to the U.S. FDA. Starting with the U.S., we will sequentially apply for approval in major countries such as Europe and do our best to expand our biosimilar portfolio into the ophthalmic disease area."

Celltrion plans to complete global approval applications for up to five biosimilars, including CT-P42, within this year. Earlier, in April and May respectively, it completed 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.