Seoul, South Korea – Celltrion, a leading South Korean biopharmaceutical company, announced today that it has received regulatory approval from the Ministry of Food and Drug Safety for its biosimilars of Prolia and Xgeva, named Stoboclo and Osenvelt, respectively. This marks the first domestic approval for biosimilars of both drugs.
Prolia and Xgeva, both based on the same active ingredient, are approved for the treatment of osteoporosis in postmenopausal women and the prevention of skeletal-related events in patients with cancer, respectively.
Celltrion conducted a global Phase 3 clinical trial involving 479 postmenopausal women with osteoporosis in four European countries. The results demonstrated that Stoboclo was biosimilar to the original drug in terms of efficacy and pharmacokinetics. Based on these findings, the company submitted applications for regulatory approval in South Korea, the United States, and Europe in December of the previous year.
Amgen's financial report for the previous year revealed that global sales of Prolia and Xgeva totaled approximately $6.16 billion.
With this approval, Celltrion aims to expand its therapeutic portfolio beyond autoimmune diseases and oncology to include new areas such as allergy, ophthalmology, and bone diseases.
"The simultaneous approval of Stoboclo and Osenvelt will provide Korean patients with a more affordable treatment option that is equally effective as the original drug," said a Celltrion official. "Building on this domestic approval, we will strive to secure regulatory approval in major global markets such as Europe and the United States as quickly as possible, solidifying our position as a first-mover and improving patient access to treatment."
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