Celltrion Inc. received regulatory clearance for three biosimilars in Australia over the past two weeks, bolstering its position in the Oceania market.
The South Korean pharmaceutical giant secured approvals from Australia’s Therapeutic Goods Administration for Eydenzelt, Stoboclo and Osenvelt, the company said Thursday. Eydenzelt, which references Regeneron’s blockbuster Eylea, targets eye diseases including myopic choroidal neovascularization and is available in both vial and pre-filled syringe formats.
The bone disease treatments Stoboclo and Osenvelt reference Amgen’s Prolia and Xgeva, which generated approximately $6.6 billion (9.2 trillion won) in global sales last year. The original drug for Eydenzelt, Eylea, posted global sales of $9.52 billion (13.33 trillion won) in the same period.
With these additions, Celltrion now has 11 products either approved or marketed in Australia. “Australia’s biosimilar-friendly environment continues to spur our growth momentum,” a company official said.
The approvals follow Celltrion’s recent regulatory victories in Europe and the United States, where the same biosimilars received marketing authorizations earlier this year. The company plans to expand its pipeline with more eye and bone disease treatments to strengthen its competitiveness in the region.
Celltrion’s aggressive global expansion comes as biosimilars increasingly gain traction in multiple therapeutic areas, offering cost-effective alternatives to expensive biological medicines while expanding patient access to critical treatments.
