Celltrion announced on the 7th that it has started global clinical trials of’CT-P42′, a biosimilar of’Ilia’, an eye disease treatment.
Through this phase 3, Celltrion plans to conduct a comparative study on the efficacy, safety, pharmacokinetics, and immunogenicity of CT-P42 and Ilia for diabetic macular edema (DME) patients in a total of 13 countries by the second half of 2022.
Aylia is a blockbuster eye disease treatment jointly developed by Bayer and Regeneron. It is used as a treatment for macular degeneration and diabetic macular edema. Ilia’s global sales in 2019 were 8.5 trillion won.
Celltrion started developing CT-P42 with the goal of approving more than one drug each year by 2030. CT-P42 is expected to be approved by the European Medicines Agency (EMA) in the first half of this year, CT-P17 (Humira biosimilar), CT-P16 (Avastin biosimilar) and CT-P39 (Xolair biosimilar) currently in global clinical trials. , CT-P41 (Prolia biosimilar), CT-P43 (Stellara biosimilar), etc. are expected to become the growth engines of Celltrion.
An official from Celltrion said, “We started developing CT-P42 with the idea that Ilia’s US monopoly will expire in November 2023,” and said, “By successfully completing global clinical trials of CT-P42, patients have access to high-quality biopharmaceuticals. I will try to expand it.” Aylia will expire in 2024 in Korea and 2025 in Europe.
In addition to Celltrion, Samsung Bioepis, Alteogen, and Samcheondang Pharmaceutical are also conducting clinical trials for AIlia’s biosimilars. Samsung Bioepis entered the third phase of global clinical trials in 10 countries including Korea and the United States from July last year. Altos Biologics, a subsidiary specializing in the development of Alteogen’s biosimilars, is ahead of Phase 3 clinical trials of Ailia biosimilars.
Samcheondang Pharmaceutical also received approval from the Ministry of Food and Drug Safety last year for a phase 3 clinical trial of the Ailia biosimilar.
Reporter Woosang Lee [email protected]
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