Tiếng ViệtEylea biosimilar CT-P42 Phase 3 52-week results revealed
Completed application for approval in major countries such as the US, Europe, and Korea
Five follow-up biosimilar product lines, including CT-P42, are on standby
Celltrion attended a global conference held in the United States and disclosed key results from the phase 3 clinical trial of Eylea biosimilar.
Celltrion announced on the 9th that it announced the results of the 52-week phase 3 global clinical trial of ‘CT-P42’, a biosimilar to Eylea (aflibercept), a biosimilar for eye disease treatment, at the ‘Academy of Vision and Ophthalmology’ (ARVO).
ARVO is the world’s largest international ophthalmology society that shares the latest knowledge and innovative treatments related to ophthalmology. This year, it was held in Seattle, USA from the 5th to the 9th.
Celltrion orally presented the 52-week results of a global phase 3 trial conducted on 348 patients with diabetic macular edema (DME) at a presentation session held on the fourth day of the academic conference. This is the first time that the long-term clinical results observed additionally from the 24-week phase 3 clinical results of CT-P42 released by Celltrion last year are being disclosed.
In the clinical trial, DME patients were randomly assigned to a CT-P42 administration group and an original drug administration group, and the effectiveness and safety of CT-P42 compared to the original drug were evaluated for 52 weeks.
According to this clinical result, the average change in best-corrected visual acuity (BCVA) in both treatment groups gradually increased compared to the baseline until week 16 and then remained stable until week 52, proving the long-term therapeutic effectiveness of CT-P42. Other secondary efficacy endpoints and safety also showed similarities.
Celltrion, which confirmed the long-term effectiveness and safety through the results of this study, expects CT-P42 to quickly penetrate the market once it receives approval in major global countries. Last year, Celltrion completed applications for CT-P42 approval in major global markets such as the United States, Korea, Canada, and Europe.
In particular, CT-P42 is one of the follow-up biosimilar products that Celltrion is targeting and is expected to contribute to the expansion of biosimilar sales upon approval. Eylea, the original drug for CT-P42, recorded global sales of approximately $9.36 billion (approximately KRW 12.168 trillion) last year.
A Celltrion official said, “As long-term data for CT-P42 has been accumulated, we have confirmed its long-term effectiveness and safety compared to the original,” and added, “We will proceed without a hitch to ensure smooth approval of biosimilars that have completed applications for approval, including CT-P42. “We will do our best to supply it to patients as quickly as possible,” he said.
