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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


Celltrion announced on August 6th that it has published the global Phase 3 clinical trial results evaluating the efficacy and safety of CT-P41, a biosimilar referencing the osteoporosis drug Prolia (ingredient: denosumab).

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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