Celltrion Completes Patient Enrollment for Global Phase 3 Clinical Trial of Aelia Biosimilar 'CT-P42'

[Asia Economy Reporter Lee Gwan-joo] Celltrion announced on the 20th that it has completed patient recruitment for the global Phase 3 clinical trial of CT-P42, a biosimilar of EYLEA (active ingredient Aflibercept), a treatment for ophthalmic diseases.

Celltrion began the global Phase 3 clinical trial of CT-P42 in February last year and recently completed patient recruitment for diabetic macular edema (DME) in a total of 13 countries, including Germany and Spain. Through this global Phase 3 clinical trial, Celltrion plans to conduct comparative clinical trials on the efficacy and safety of CT-P42 and EYLEA, and aims to secure results within the year and proceed with the approval process.

EYLEA, developed by Regeneron in the United States, is a blockbuster ophthalmic disease treatment used for wet age-related macular degeneration (wAMD) and diabetic macular edema (DME). As of last year, the global sales of EYLEA amounted to approximately 11.5 trillion KRW.

The substance patent for EYLEA will expire in November 2023 in the United States and in May 2025 in Europe, and Celltrion plans to commercialize CT-P42 in line with the expiration of the original drug’s substance patent.

A Celltrion official stated, “The development process, including global patient recruitment for the commercialization of CT-P42, is progressing smoothly,” and added, “Celltrion plans to accelerate portfolio expansion into ophthalmic diseases following autoimmune disease treatments and anticancer drugs.”

In addition to CT-P42, Celltrion is accelerating the development of follow-up pipelines with the goal of obtaining approval for at least one drug annually until 2030. Global Phase 3 clinical trials are underway for CT-P39 (Xolair biosimilar), CT-P41 (Prolia biosimilar), and CT-P43 (Stelara biosimilar), and in the fourth quarter of last year, Phase 1 clinical trials began for CT-P47 (Actemra biosimilar), an autoimmune disease treatment.

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