Celltrion Reveals Phase 3 Clinical Trial Results of Aflibercept Biosimilar 'CT-P42'

Celltrion has disclosed the global Phase 3 clinical trial results of 'CT-P42,' a biosimilar (biopharmaceutical generic) under development for the ophthalmic disease treatment drug 'Eylea' (active ingredient Aflibercept).

Aerial view of Celltrion Global Biotechnology Research Center
[Photo by Celltrion]

On the 30th (local time), Celltrion revealed detailed data from the global Phase 3 clinical trial of CT-P42 for the first time at the 2023 American Society of Retina Specialists (ASRS) Annual Meeting held in Seattle, USA. ASRS, a globally renowned academic conference related to ophthalmic diseases, is in its 41st year and is being held in Seattle from the 28th through the 1st of next month.

Celltrion presented the clinical trial results through an oral presentation during the 'Late-breaking Abstracts' session on the third day of the conference. The trial was conducted on 348 patients with diabetic macular edema (DME) across a total of 13 countries worldwide, including Spain and Hungary.

Celltrion randomly assigned patients into two groups: the CT-P42 treatment group and the original drug treatment group, measuring the change in best corrected visual acuity (BCVA) from baseline to week 8 as the primary endpoint. The results showed that CT-P42 met the pre-defined equivalence margin of ±3 letters. Secondary endpoints, including other efficacy measures, safety, and immunogenicity assessments, also demonstrated similar trends compared to the original drug.

In addition to diabetic macular edema, Eylea's approved indications in Korea include ▲wet age-related macular degeneration (wAMD) ▲retinal vein occlusion-associated macular edema ▲choroidal neovascularization. On the 26th, Celltrion applied for marketing authorization for the full-label indications with the Korean Ministry of Food and Drug Safety, and last month submitted an application to the U.S. Food and Drug Administration (FDA) for approval covering all indications except pediatric use. The company plans to sequentially apply for approvals in major global markets such as Europe.

Regeneron's wet age-related macular degeneration treatment 'Eylea' [Photo by Bayer Korea]

Developed by Regeneron, Eylea is an antibody drug administered via direct intravitreal injection into the eye, which binds to and inhibits vascular endothelial growth factor (VEGF) receptors. Although 'Lucentis,' which has similar indications, was launched earlier, Eylea's longer dosing interval has been cited as a factor for its faster market dominance due to reduced patient burden. Eylea's global sales reached $9.75699 billion (approximately 12.45 trillion KRW) last year.

However, the need for direct eye injections has raised concerns about improving the administration method. After returning to active management in March, Celltrion Group Chairman Seo Jung-jin stated at a press conference that regarding CT-P42, "(The original) is directly injected into the eye, so patients find it difficult and painful," and expressed intentions to develop a biobetter similar to 'Remsima SC.'

Previously, Celltrion developed Remsima SC, a subcutaneous injection (SC) formulation of the autoimmune disease treatment drug 'Remsima' (active ingredient Infliximab), which was originally an intravenous (IV) formulation, enhancing patient convenience. Chairman Seo personally met with European medical professionals, judged that there was strong demand for formulation changes, and directly instructed the development. Leveraging the advantage of the SC formulation, which neither biosimilars nor the original drug had, Remsima SC is accelerating market penetration. The U.S. FDA has unusually recommended approval as a new drug rather than a biosimilar, and related procedures are currently underway. If the formulation change development of CT-P42 succeeds, it is highly likely that achievements such as FDA new drug approval will be replicated.

A Celltrion official said, “The global clinical trial results confirming therapeutic equivalence and safety of CT-P42 compared to the original drug were first disclosed at a globally prestigious international academic conference, attracting significant interest from medical professionals and industry stakeholders. Based on these clinical results, we will proceed smoothly with approval procedures in each country and do our best to supply high-quality biopharmaceuticals to the global market.”

Meanwhile, other domestic companies are also actively conducting research and development to capture the market for Eylea biosimilars. Samsung Bioepis disclosed in April the Phase 3 clinical results demonstrating equivalence of 'SB15' to the original drug. Samchundang Pharm is developing 'SCD411,' and Alteogen is developing 'ALT-L9.'

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