Will 'Eylea' Eye Injections Become Seo Jung-jin's Next 'Similar Biologic Drug'?

Celltrion's 'CT-P42', a biosimilar (biopharmaceutical generic) under development for the ophthalmic disease treatment drug 'Eylea' (active ingredient Aflibercept), has confirmed efficacy and safety comparable to the original in the interim results of its global Phase 3 clinical trial. Seo Jung-jin, Chairman of the Celltrion Group who recently returned to frontline management, stated, "Patients experience pain during the injection process," and expressed intentions to develop a biobetter similar to 'Remsima SC,' drawing attention to future market expansion strategies.

Celltrion Global Biotechnology Research Center
[Photo by Celltrion]

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On the 3rd, Celltrion announced that the 24-week results of the global Phase 3 clinical trial of CT-P42 met the primary efficacy endpoint and showed similar trends in secondary endpoints including efficacy, safety, and immunogenicity assessments. The trial is being conducted over 52 weeks with 348 patients suffering from diabetic macular edema (DME) across 13 countries including Germany and Spain. The results announced are interim data up to 24 weeks.

Celltrion divided subjects into two groups: one receiving CT-P42 and the other receiving the original drug. The primary endpoint was the change in best-corrected visual acuity (BCVA) measured at 8 weeks compared to baseline. The results showed that CT-P42 met the pre-defined equivalence margin of ±3 letters. Similar trends were observed in secondary endpoints such as other efficacy measures, safety, and immunogenicity assessments compared to the original drug. Celltrion plans to complete the remaining Phase 3 trials and submit CT-P42 for approval in major countries including the United States and Europe within this year.

In addition to diabetic macular edema, Eylea's approved indications in South Korea include ▲wet age-related macular degeneration ▲retinal vein occlusion macular edema ▲choroidal neovascularization. Currently, Celltrion is not conducting Phase 3 trials for other indications. As a biosimilar, it is expected that Celltrion will pursue label expansion to secure full indications in the future.

Eylea is an antibody drug injected directly into the vitreous of the eye, working by binding to and inhibiting vascular endothelial growth factor (VEGF) receptors. Although 'Lucentis', which has similar indications, was launched earlier, Eylea's longer dosing interval reduces patient burden, which is considered a key factor in its rapid market dominance. Eylea's global sales reached $9.75699 billion (approximately 12.78 trillion KRW) last year.

Seo Jung-jin, Chairman of the Celltrion Group, is speaking at an online press conference held last month. [Photo by Celltrion]

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Seo Jung-jin, Chairman of the Celltrion Group, also expressed a willingness to improve this injection method, raising expectations for additional development through formulation changes. At a press conference held on the 29th of last month after returning to frontline management, Seo stated regarding CT-P42, "Because the original drug is injected directly into the eye, patients find it difficult and painful," and added, "We plan to develop a biobetter similar to Remsima SC."

Previously, Celltrion developed Remsima SC, a subcutaneous injection (SC) formulation of the autoimmune disease treatment Remsima (active ingredient infliximab), which was originally administered intravenously (IV), improving patient convenience. After meeting with local European medical professionals, Chairman Seo judged that there was strong demand for formulation changes and personally directed the development. Leveraging the advantage of the SC formulation, which neither the biosimilar nor the original had, Remsima SC has accelerated market penetration. The U.S. Food and Drug Administration (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, similar achievements such as FDA new drug approval are highly likely.

A Celltrion official said, "CT-P42 confirmed equivalence and similarity to the original drug in the 24-week global Phase 3 results," adding, "We will proceed with the remaining clinical procedures without delay and do our best to accelerate the global approval application within this year." Celltrion is also developing follow-up biosimilars including 'CT-P39' (Xolair biosimilar), 'CT-P41' (Prolia biosimilar), 'CT-P43' (Stelara biosimilar), and 'CT-P47' (Actemra biosimilar), aiming for the highest number of biosimilar approval applications this year.

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

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Meanwhile, other domestic companies are also actively conducting research and development to capture the market for Eylea biosimilars. Samsung Bioepis completed the Phase 3 clinical trial of 'SB15' last year and has finished analyzing the results, which will be disclosed soon through academic presentations. Samchundang Pharmaceutical completed multinational Phase 3 trials of 'SCD411' last month and demonstrated equivalence to the original. Alteogen recently finished patient recruitment for the Phase 3 trial of 'ALT-L9'.

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