Celltrion said it confirmed the efficacy of CT-P42, a biosimilar referencing Eylea (ingredient: aflibercept), in a phase 3 study. The company presented the trial results during the FLORetina–ICOOR 2023  conference.

Eylea is a blockbuster ophthalmic drug developed by Regeneron and treats wet age-related macular degeneration (wAMD) and diabetic macular edema (DME). Eylea is expected to reach substance patent expiration in the U.S. in June 2023 and in Europe in May 2025. The drug had sales of about $9.7 billion worldwide last year.

FLORetina–ICOOR 2023 is an international conference sharing the latest research and treatment methods related to retinal diseases and was held for four days from last Thursday to Sunday in Rome, Italy.

During the convention, Celltrion presented the 24-week global phase 3 results on the efficacy and safety of CT-P42 compared to Eylea in diabetic macular edema (DME), involving 348 patients from 13 countries, including Spain, Hungary, and the Czech Republic.

In the clinical trial, Celltrion confirmed that the change in the best corrected visual acuity (BCVA) at 8 weeks for the CT-P42 group and the original drug group was within the equivalence range.

The trial also showed similar results to the original drug in terms of other secondary efficacy evaluation variables up to 24 weeks, as well as safety and immunogenicity.

Based on these phase 3 clinical trial results, Celltrion plans to accelerate the global market entry of CT-P42.

“Based on the global phase 3 clinical trial results of CT-P42, we are smoothly progressing with the product licensing procedures in key countries domestically and internationally,” a company official said. “CT-P42 is a product that expands Celltrion's influence into the ophthalmology market, in addition to its existing portfolio of autoimmune diseases and cancer treatments."

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