(Health Korea News / Soon-ho Lee) ‘CT-P41’, a biosimilar to osteoporosis treatment PROLIA (ingredient name: denosumab) developed by Celltrion, is launched in earnest after confirming non-inferiority to the original in a global phase 3 clinical trial Let’s start preparing.
Celltrion announced the results of a global phase 3 clinical trial containing these contents at the recently held ‘2024 American Society for Bone and Mineral Research (ASBMR)’.
ASBMR is a representative bone disease-related society that covers areas such as bones and the musculoskeletal system, with over 2,500 experts attending from over 50 countries around the world. This year’s annual conference was held in Toronto, Canada for four days from the 27th to the 30th of this month.
The clinical study announced by Celltrion this time is the result of a 78-week evaluation of a global phase 3 clinical trial that analyzed the effectiveness and safety of CT-P41. Celltrion compared safety, including efficacy, pharmacodynamics, pharmacokinetics, and immunogenicity, between CT-P41 and the original drug in 479 female patients with postmenopausal osteoporosis.
As a result of the study, the primary efficacy evaluation index between CT-P41 and the original drug administration group met the equivalence standard, and efficacy and safety were confirmed at 78 weeks in the patient group that received CT-P41 at 52 weeks after administration of the original drug.
Based on these research results, Celltrion plans to proceed with the approval process in major global countries without a hitch and introduce the product to the market as soon as possible. Celltrion completed its application for CT-P41 product approval to the European Medicines Agency (EMA) this year, following the U.S. Food and Drug Administration (FDA) and the Korean Ministry of Food and Drug Safety last year.
Prolia, the original drug of CT-P41, is a treatment for osteoporosis, but the same main ingredient is also a drug approved under the product name ‘XGiva’, which prevents and treats bone metastasis complications in cancer patients. Last year’s global sales were about $6.16 billion (about KRW 8.08 trillion), and the patent is scheduled to expire in the U.S. and Europe in February and November 2025, respectively.
A Celltrion official said, “This conference was a meaningful time to confirm the effectiveness and safety of CT-P41 compared to the original drug,” adding, “We will proceed with the approval process in major global countries without a hitch and speed up entry into the market worth about 8 trillion won.” “I plan to release it,” he said.
Meanwhile, Celltrion is expanding its portfolio in various fields such as bone diseases, eye diseases, and allergic diseases, following existing autoimmune disease treatments and anticancer drugs, and is raising expectations for increased sales. Celltrion plans to secure 22 portfolios by 2030.
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