Celltrion's 'Ailia Similar', Proven Long-Term Efficacy Over One Year

Celltrion announced on the 9th that it presented the 52-week results of the global Phase 3 clinical trial of CT-P42, a biosimilar developed from Eylea, a treatment for ophthalmic diseases, at the Association for Research in Vision and Ophthalmology (ARVO). ARVO is the world's largest international ophthalmology conference that shares the latest insights and innovative treatments related to eye diseases. It was held over five days from the 5th to the 9th of this month in Seattle, USA.

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

On the fourth day of the conference, Celltrion orally presented the 52-week results of the Phase 3 trial conducted on 348 patients with diabetic macular edema (DME). This is the first time additional long-term clinical results have been disclosed since Celltrion revealed the 24-week results of CT-P42’s Phase 3 trial last year.

In this clinical trial, DME patients were randomly assigned to either the CT-P42 treatment group or the original drug treatment group, and the efficacy and safety of CT-P42 compared to the original drug were evaluated over 52 weeks. As a result, the mean change in best corrected visual acuity (BCVA) gradually increased up to week 16 in both treatment groups compared to baseline, and then remained stable through week 52, demonstrating the long-term therapeutic efficacy of CT-P42. Similarities were also observed in other secondary efficacy endpoints and safety profiles.

Celltrion expects that CT-P42, which has confirmed long-term efficacy and safety through this study, will be approved in major global countries and rapidly penetrate the market. Currently, CT-P42 has completed regulatory submissions in major global markets including the United States, South Korea, Canada, and Europe.

Eylea is an ophthalmic disease treatment developed jointly by Regeneron in the United States and Bayer in Germany for conditions such as macular degeneration and macular edema. Regeneron handles sales in the United States, while Bayer manages global sales in other regions. Last year, combined sales by the two companies reached $9.36 billion (approximately 13 trillion KRW), making it a global blockbuster.

A Celltrion official stated, "As long-term data for CT-P42 accumulates, we have confirmed its long-term efficacy and safety compared to the original drug. We will do our best to ensure that the remaining procedures for the smooth approval of CT-P42 and other biosimilars for which regulatory submissions have been completed proceed without delay, so that we can supply them to patients as soon as possible."

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