Celltrion Secures First Approval for Prolia Biosimilar in Korea
On the 22nd, Celltrion announced that it obtained simultaneous approvals from the Ministry of Food and Drug Safety for the osteoporosis treatment Stavoklone (a biosimilar of Prolia) and the cancer-related bone metastasis treatment Oseni Belt (a biosimilar of Xgeva). Both biosimilars contain the active ingredient denosumab and are indicated for their respective original uses.
Stavoklone was approved for all indications of Prolia, including the treatment of osteoporosis in postmenopausal women, increasing bone mass in men, and other related indications. Similarly, Oseni Belt was approved for all indications of Xgeva, including the prevention of skeletal-related complications from bone metastases in cancer patients and the treatment of giant cell tumors of the bone.
The approvals were based on the results of global Phase 3 clinical trials. Celltrion submitted regulatory applications for Stavoklone and Oseni Belt as biosimilars last December. With these approvals, Celltrion has become the first mover in the Korean market for biosimilars of Prolia and Xgeva.
Prolia and Xgeva are blockbuster drugs, generating $6.16 billion (approximately 8 trillion KRW) in global revenue last year. In addition to this approvals, Celltrion has submitted applications for approval in the U.S. and Europe and is awaiting decisions.
A Celltrion representative stated, “The simultaneous approval of Stavoklone and Oseni Belt allows us to provide patients with treatment options that are equivalent in efficacy to existing therapies but more cost-effective. Building on this approval, we aim to expedite regulatory approvals in key global markets such as Europe and the U.S. to solidify our competitive edge as a first mover.”