Celltrion Initiates Phase 1 Clinical Trial for Osteoporosis Treatment Biosimilar
[Asia Economy Reporter Cho Hyun-ui] Celltrion announced on the 14th that its biosimilar of the osteoporosis treatment 'Prolia,' named 'CT-P41,' has commenced Phase 1 clinical trials.
This Phase 1 trial aims to evaluate safety in healthy subjects. It is scheduled to begin in September and is expected to be completed by the first half of next year.
Prolia is an antibody biopharmaceutical from the multinational pharmaceutical company Amgen, used to treat osteoporosis and bone loss in cancer patients. According to Amgen's 2019 financial report, the market size reached 3.2 trillion KRW in sales.
Celltrion plans to initiate global Phase 3 clinical trials of CT-P41 in the first half of next year and complete preparations for commercialization by February 2025, when Prolia's U.S. substance patent expires.
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A Celltrion official stated, "We will successfully conduct CT-P41 clinical trials and introduce the product early to major global markets such as the U.S. and Europe," adding, "We plan to reliably supply high-quality biosimilar products at reasonable prices."
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