Celltrion Receives MFDS Approval for Phase 3 Clinical Trial Plan of Prolia Biosimilar
[Asia Economy Reporter Minji Lee] Celltrion announced on the 30th that it has received approval from the Ministry of Food and Drug Safety of Korea for a Phase 3 clinical trial plan to evaluate the efficacy, pharmacokinetics, pharmacodynamics, and safety of CT-P41 and Prolia in patients with postmenopausal osteoporosis.
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The company stated, "Through the clinical trial, we plan to demonstrate the similarity of CT-P41 to the original drug Prolia in terms of efficacy, pharmacokinetics, pharmacodynamics, and safety results."
This content was produced with the assistance of AI translation services.
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