Celltrion Presents Phase 3 Results of Aflibercept Biosimilar 'CT-P42' at European Conference

Ophthalmic Disease Treatment Biosimilar
Equivalence and Tolerability Confirmed Compared to Original
Accelerating Entry into 13 Trillion Won Global Market

Celltrion announced on the 4th that it presented the global Phase 3 clinical trial results of the ophthalmic disease treatment biosimilar 'CT-P42' of Aflibercept (brand name Eylea) at the 'European Retina Imaging Society (FLORetina?ICOOR 2023)' academic conference.

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

The European Retina Imaging Society is an international conference that shares the latest knowledge on retinal diseases and related treatments. It was held for four days from the 30th of last month to the 3rd of this month (local time) in Rome, Italy.

On the third day of the conference, Celltrion gave an oral presentation on the topic "Efficacy and Safety of CT-P42 Compared to Reference Aflibercept in Diabetic Macular Edema (DME)" based on the global Phase 3 clinical trial results involving 348 patients from 13 countries including Spain, Hungary, and the Czech Republic over 24 weeks.

In the clinical trial, Celltrion randomly assigned patients to the CT-P42 treatment group and the original drug treatment group, confirming that the change in best corrected visual acuity (BCVA) at week 8 was within the equivalence margin (±3 letters) for the primary endpoint. Other secondary efficacy endpoints up to week 24, as well as safety and immunogenicity, showed similar results to the original drug.

Based on the Phase 3 clinical trial results, Celltrion plans to accelerate the global market entry of CT-P42. The original drug Eylea, of which CT-P42 is a biosimilar, recorded sales of $9.75699 billion (approximately KRW 12.6841 trillion) worldwide 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.

Celltrion has already completed regulatory submissions for CT-P42 in the U.S. (June), South Korea (July), Canada (July), and Europe (November) this year.

A Celltrion official stated, "Based on the global Phase 3 clinical trial results of CT-P42, we are smoothly progressing with the product approval process in major countries domestically and internationally. CT-P42 is a product that pioneers the ophthalmic disease market in addition to Celltrion’s existing autoimmune disease and anticancer drug portfolios, and we will continue to expand its influence in the future."

Meanwhile, Celltrion plans to complete a portfolio of 11 biosimilar products by 2025 and secure new drugs in promising fields such as antibody-drug conjugates (ADC), multi-specific antibodies, and microbiomes.

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