Celltrion Begins Global Phase 3 Clinical Trial for Ophthalmic Disease Treatment Biosimilar

[Asia Economy Reporter Seo So-jung] Celltrion announced on the 7th that it has commenced the global Phase 3 clinical trial of 'CT-P42,' a biosimilar (biopharmaceutical generic) of the ophthalmic disease treatment drug 'Eylea.'

This Phase 3 clinical trial will be conducted on patients with diabetic macular edema in a total of 13 countries until the second half of next year. The study plans to compare the efficacy, safety, pharmacokinetics, and immunogenicity of CT-P42 and Eylea.

Eylea, developed by Regeneron in the United States, is a blockbuster ophthalmic disease treatment drug used for treating macular degeneration and diabetic macular edema. The global sales of Eylea were approximately KRW 8.5 trillion as of 2019.

Celltrion has embarked on the development of CT-P42 with the goal of obtaining approval for at least one pharmaceutical product annually by 2030. CT-P42 is expected to become Celltrion's next-generation growth engine alongside CT-P17 (Humira biosimilar), which is anticipated to receive approval from the European Medicines Agency (EMA) in the first half of this year, and other biosimilars currently in global clinical trials such as CT-P16 (Avastin biosimilar), CT-P39 (Xolair biosimilar), CT-P41 (Prolia biosimilar), and CT-P43 (Stelara biosimilar).

A Celltrion official stated, “Celltrion initiated the development of CT-P42 based on the fact that Eylea's U.S. exclusivity expires in November 2023,” adding, “We will strive to successfully complete the global clinical trial of CT-P42 to expand patients' access to high-quality biopharmaceutical treatments.”