Celltrion Announces Phase 1 Results of Osteoporosis Treatment Biosimilar at American Society for Bone and Mineral Research Conference

Osteoporosis Treatment Biosimilar
'CT-P41'
Pharmacokinetic Equivalence and Safety Confirmed

Celltrion announced on the 17th that it presented the Phase 1 clinical trial results of the osteoporosis treatment biosimilar 'CT-P41' (active ingredient denosumab), a biosimilar of 'Prolia,' at the American Society for Bone and Mineral Research (ASBMR) held in Vancouver, Canada, from the 13th to the 16th (local time).

Incheon Songdo Celltrion Plant 2 Overview. / Incheon - Photo by Hyunmin Kim kimhyun81@

Prolia is an osteoporosis treatment drug by the multinational pharmaceutical company Amgen. According to IQVIA, it recorded sales of approximately $5.83 billion (about 7.54 trillion KRW) last year, and its patent is expected to expire in 2025. Celltrion began Phase 1 and Phase 3 clinical trials simultaneously in 2021 to develop a biosimilar of Prolia.

In the Phase 1 clinical trial announced this time, Celltrion evaluated the pharmacokinetics (PK) and safety of CT-P41 over nine months in 154 healthy subjects. They demonstrated pharmacokinetic equivalence with the control group, Prolia, in the primary endpoint and confirmed reductions in key bone metabolism markers 's-CTX' and 'P1NP' as well as similar safety profiles.

Following the Phase 1 results, Celltrion plans to announce the global Phase 3 clinical trial results conducted on osteoporosis patients as soon as possible. Additionally, they aim to accelerate the commercialization of CT-P41 with plans to submit approval applications to major regulatory agencies, including the U.S. Food and Drug Administration (FDA), within this year.

Besides CT-P41, Celltrion stated that it is sequentially proceeding with clinical and approval procedures to expand its pipeline, including biosimilars such as CT-P39 for Xolair, CT-P42 for Eylea, CT-P43 for Stelara, CT-P47 for Actemra, and CT-P53 for Ocrevus.

A Celltrion representative said, "At ASBMR, where medical professionals worldwide in the bone metabolism field gather attention, we disclosed data on healthy subjects for CT-P41, proving pharmacokinetic equivalence compared to the original drug. Including previously launched products such as Remsima, Truxima, and Uplima, we plan to launch a total of 11 products, including the Prolia biosimilar, by 2025 and expand our influence in the market."

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