Celltrion Applies for IND for Phase 3 Clinical Trial of Osteoporosis Biosimilar in the US
[Asia Economy Reporter Cho Hyun-ui] Celltrion announced on the 14th that it has submitted the clinical phase 3 trial plan (IND) for 'CT-P41', a biosimilar of the osteoporosis treatment drug 'Prolia', to the U.S. Food and Drug Administration (FDA).
The phase 3 clinical trial will be conducted on a total of 416 participants across 5 countries, aiming for completion in the first half of 2024. Celltrion began phase 1 clinical trials in August last year and is currently conducting clinical trials.
Prolia is an antibody biopharmaceutical from the multinational pharmaceutical company Amgen, used for treating osteoporosis and bone loss in cancer patients. The market size was approximately 3 trillion KRW in sales based on 2019 business performance data.
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A Celltrion official stated, "We will successfully conduct the phase 3 clinical trial of CT-P41 in the U.S. and continue to supply high-quality biopharmaceuticals at reasonable prices worldwide."
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