Celltrion announced on the 4th that its bone disease treatment biosimilars Stoboclo and Osenvelt—biosimilars of Prolia and Xgeva (active ingredient denosumab)—have received approval from the U.S. Food and Drug Administration (FDA). Prolia and Xgeva contain the same active ingredient but are approved for different indications: Prolia for osteoporosis treatment and Xgeva for preventing skeletal-related complications in cancer patients with bone metastases.
With this approval, Stoboclo has been authorized for the treatment of postmenopausal osteoporosis, while Osenvelt has been approved for preventing skeletal-related events in patients with bone metastases and treating giant cell tumors of bone, covering all indications held by the original drugs in the U.S.
Celltrion applied for FDA approval of Stoboclo and Osenvelt after conducting a global Phase 3 clinical trial involving 479 osteoporosis patients worldwide. The study confirmed their efficacy, equivalence, and pharmacokinetic similarity to the original drugs.
The original products, Prolia and Xgeva (denosumab), recorded combined global sales of approximately $6.599 billion (KRW 9.2 trillion) last year. The U.S. alone accounted for 67% of global sales, generating around $4.392 billion (KRW 6.15 trillion). With a prior patent settlement agreement reached with Amgen, the original drug developer, Celltrion plans to launch both products in the U.S. as early as this year, targeting the world’s largest pharmaceutical market.
Notably, Celltrion secured a ‘First Mover’ position by becoming the first company to receive domestic approval for a competing product in November last year. With subsequent approvals from the European Commission (EC) last month and now the FDA, the company is accelerating efforts to introduce its biosimilars in key global markets to drive revenue growth.
A Celltrion representative stated, “With a series of biosimilar approvals in major global markets, we have once again demonstrated our in-house product development capabilities. We will focus on successfully completing approval procedures for our remaining pipeline while ensuring that our approved products quickly penetrate the market to maximize sales growth.”
