Celltrion presents clinical results of Prolia biosimilar
By Hwang, Byung-woo
24.08.06 09:47:28
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CT-P41's Phase 3 clinical trial results at 78-week published in the international osteoporosis journal¡¦the efficacy and safety have been confirmed
To enter a global market sized KRW 8 trillion¡¦have completed applying for approvals in countries, including the United States and Europe
The Phase 3 study compared the safety profile, including the efficacy, pharmacodynamics, pharmacokinetics, and immunogenicity, of CT-P41 to the original drug, in 479 female patients with osteoporosis after menopause. The study was conducted in four European countries.
The results showed that at a 78-week evaluation, the primary endpoints of the efficacy and pharmacodynamics between CT-P41 and the original drug met the equivalence criteria.
Additionally,
Hwang, Byung-woo(tuai@dailypharm.com)
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