Celltrion Reveals Phase 3 Results of Prolia Biosimilar... "Efficacy and Safety Confirmed"

Osteoporosis Treatment Biosimilar 'CT-P41' for Prolia
"Expected to Enter Approval Process Within the Year"

Celltrion announced on the 24th that it disclosed the global Phase 3 clinical trial results of the osteoporosis treatment biosimilar 'CT-P41' (active ingredient denosumab), a biosimilar of 'Prolia,' on the 23rd.

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

The recently announced Phase 3 clinical trial was conducted by Celltrion in a total of four countries, including Poland and Estonia, involving 477 postmenopausal women with osteoporosis, with clinical results up to 52 weeks.

Celltrion evaluated the change in lumbar spine bone mineral density from baseline as the primary endpoint between the CT-P41 treatment group and the original drug treatment group. The evaluation results showed that the difference between the original drug and the CT-P41 group fell within the pre-defined equivalence margin, thereby demonstrating equivalence. Secondary endpoints, including key bone metabolism markers 's-CTX' and 'P1NP,' also showed similar trends between the original drug and CT-P41, confirming pharmacodynamic similarity.

In terms of safety, the incidence rates of adverse reactions and serious adverse events after administration were similar between the original drug group and the CT-P41 group, and no significant differences were observed in other parameters.

Celltrion plans to complete the remaining Phase 3 clinical trials of CT-P41 and sequentially apply for approval in major countries, including the United States, within this year.

Prolia is an osteoporosis treatment drug by the multinational pharmaceutical company Amgen, which is also approved under the brand name 'Xgeva' for the prevention of bone metastasis complications in cancer patients with the same active ingredient. According to IQVIA data, it recorded sales of $5.83 billion (approximately KRW 7.54 trillion) 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. Notably, based on these clinical results and equivalence data, Celltrion has completed consultations with the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA) to enable approval as a biosimilar for both Prolia and Xgeva without additional separate clinical trials.

A Celltrion representative stated, "CT-P41 demonstrated efficacy equivalence compared to the original drug in the global Phase 3 clinical trial and confirmed safety similarity. We plan to quickly complete the remaining clinical procedures and enter the approval process within this year." The representative added, "Following our strengths in autoimmune diseases and oncology, Celltrion will continue to expand its product portfolio into various indications such as osteoporosis, allergic diseases, and ophthalmic diseases, moving one step closer to achieving KRW 12 trillion in sales by 2030."

Meanwhile, starting next year, Celltrion plans to sequentially launch five new biosimilar pipelines, including the Prolia-Xgeva biosimilar. Through this, the company aims to complete a portfolio of 11 products by 2025.

This content was produced with the assistance of AI translation services.