2024-05-10 00:02:29
Celltrion participates in the American Society of Vision and Ophthalmology
Eylea, a global blockbuster treatment for macular degeneration worth ‘KRW 12 trillion’
Competition to dominate the biosimilar market… Epis product launch this month
Competition from Celltrion, Samsung Bioepis, Alteogen, etc.
Celltrion announced the launch of a biosimilar of EYLEA (ingredient name: aflibercept), a treatment for eye diseases, through the ‘The Association for Research in Vision and Ophthalmology (ARVO)’ held in Seattle, USA on the 5th (local time). It was announced on the 9th that the results of the 52-week phase 3 global clinical trial of ‘CT-P42’ were announced. ARVO is the world’s largest international society in the field of ophthalmology that shares the latest knowledge and innovative treatments related to ophthalmology.
In the case of Celltrion, the 52-week results of the CT-P42 global phase 3 clinical trial were presented orally at a presentation session held on the fourth day of this academic conference. This clinical trial was conducted on 348 patients with diabetic macular edema (DME). Following the 24-week results of the CT-P42 phase 3 clinical trial released last year, additionally observed long-term clinical results were disclosed for the first time.
The clinical trial was conducted by randomly assigning DME patients to the CT-P42 administration group and the original drug (Eylea) administration group and evaluating the effectiveness and safety of CT-P42 compared to the original drug for 52 weeks. In both administration groups, the average change in best-corrected visual acuity (BCVA) gradually increased compared to the baseline until week 16 and remained stable until week 52. It has proven the long-term treatment effectiveness of CT-P42 at a similar level to the original. Similarities were also shown in other secondary efficacy endpoints and safety.
As a result of reconfirming the long-term effectiveness and safety of Celltrion CT-P42, it is expected that entry into major global countries and approval will accelerate. Currently, Celltrion has completed applications for CT-P42 approval in major markets such as Korea, the United States, Europe, and Canada.
A Celltrion official said, “CT-P42 has proven its effectiveness and safety through accumulation of long-term clinical data,” and added, “We will do our best to proceed with the remaining procedures without a hitch for smooth approval and ensure that it is quickly supplied to patients.”
The original product, Eylea, is a medicine jointly developed by Bayer of Germany and Regeneron of the United States and released in 2011. It has indications for wet macular degeneration, diabetic retinopathy, and diabetic macular edema. It has a mechanism to inhibit the formation of new blood vessels by binding to vascular endothelial growth factor (VEGF). As of last year, global sales were approximately 17 trillion won. It is known that the domestic market is worth about 100 billion won.
The domestic patent expired last January, and the U.S. patent was released starting this month. Ahead of the expiration of patents in major countries, domestic and foreign pharmaceutical and bio companies are competing to dominate the Eylea biosimilar market. In Korea, Celltrion, Samsung Bioepis, Alteogen, and Samchundang Pharmaceutical are pursuing the Eylea biosimilar market.
In particular, Samsung Bioepis is making the fastest progress. Last February, it received product approval from the Ministry of Food and Drug Safety under the name ‘Apilibu’, and was registered for reimbursement within two months and launched this month. We signed a partnership with Samil Pharmaceutical and began full-fledged domestic sales. In the case of Samsung Bioepis, ‘Amelibu’, a biosimilar to Lucentis (ranibizumab), another macular degeneration treatment, is also on the market. It is evaluated that the company has an advantage in dominating the market by having a lineup of two biosimilars in the field of ophthalmic diseases.
Alteogen is conducting a global phase 3 clinical trial for Eylea biosimilar ‘ALT-L9’. The goal is to complete clinical trials within the first half of this year. We are planning to apply for product approval in 12 countries within this year and officially launch it next year. Samchundang Pharmaceutical completed the application for domestic product approval for the biosimilar product ‘SCD411’ in November last year. Approval was applied for two dosage forms: vial (bottle) and prefilled syringe (filled injection). In the case of overseas, exclusive supply contracts have been signed in major European countries.
Meanwhile, Celltrion plans to focus on continuous product development and investment to expand its biosimilar product line to 11 by 2025, in addition to the 6 commercialized products. The goal is to achieve annual sales of 12 trillion won by 2030 by establishing a total of 22 product lineups.
Kim Min-beom, Donga.com reporter mbkim@donga.com
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2024-05-10 00:02:29