Celltrion Secures Additional Interchangeability Status for Stoqulo-Osenbelt in the U.S.

Interchangeability Approval Granted for All Indications

Celltrion announced on October 30 that it has additionally obtained interchangeability status from the U.S. Food and Drug Administration (FDA) for its biosimilar “Stoqulo-Osenbelt” (ingredient: denosumab), a treatment for bone diseases, which is a biosimilar to “Prolia-Xgeva.”

Celltrion

Interchangeability status allows a biosimilar to be substituted for the original drug at the pharmacy level without the intervention of a physician.

Celltrion received FDA approval for Stoqulo-Osenbelt in February and has now secured interchangeability status in the U.S. in about eight months.

With this approval, Stoqulo-Osenbelt has been recognized as interchangeable for all indications held by the original drugs, including osteoporosis in postmenopausal women, prevention of skeletal-related events in patients with bone metastases from cancer, and giant cell tumor of bone.

The original products for Stoqulo and Osenbelt, Prolia and Xgeva, recorded a combined global annual sales of approximately USD 6.599 billion (about KRW 9.2 trillion) last year, with the U.S. market accounting for around USD 4.392 billion (about KRW 6.15 trillion), which is about 67% of the total.

Starting with domestic approval for Stoqulo and Osenbelt in November last year, Celltrion subsequently obtained product approvals in Europe and the U.S. in February this year. The company has also received additional approvals in Australia and Canada, continuing to secure regulatory clearance sequentially in major global markets. In the U.S., Celltrion began full-scale market entry with a product launch in early July.

In particular, the additional acquisition of interchangeability status in the U.S. is seen as further strengthening Celltrion’s position in the global denosumab market. As substitution at the pharmacy level becomes possible, patient access to treatment is expected to improve, and the company’s market competitiveness is anticipated to increase further.

A Celltrion representative stated, “By obtaining interchangeability status for all indications held by the original drugs, we expect to enhance patient access and strengthen trust in the market, especially in key therapeutic areas such as osteoporosis in postmenopausal women and skeletal-related complications in cancer patients. In particular, we aim to further solidify our position in the global denosumab market by expanding our market share in the large U.S. market.”

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