Celltrion Obtains Approval for Idengel, Stovoclo, and Osenbelt Products in Australia

"Australia, a Leading Biosimilar-Friendly Country...
Expected to Drive Sales Growth"

Celltrion recently announced on the 10th that it has obtained product approvals from the Australian Therapeutic Goods Administration (TGA) for the ophthalmic treatment 'IdenZelt' and the bone disease treatments 'Stovoclo' and 'Osenbelt'.

According to Celltrion, IdenZelt was approved for the indication of myopic choroidal neovascularization. The approved formulations are two types: injection (vial) and prefilled syringe (PFS). The original drug of IdenZelt, Eylea, is a blockbuster ophthalmic disease treatment that achieved global sales of $9.523 billion (approximately KRW 13.3322 trillion) last year. Celltrion expects IdenZelt to be the first biosimilar among related competitors to receive approval in Australia, allowing it to secure an early market position and rapidly penetrate the market.

Stovoclo was approved for postmenopausal osteoporosis in women, and Osenbelt was approved for the prevention of skeletal-related complications in patients with bone metastatic cancer and for giant cell tumor of bone, covering all indications held by the original drugs in Australia. The original products of Stovoclo and Osenbelt, Prolia and Xgeva, respectively, had combined global annual sales of approximately $6.599 billion (about KRW 9.2 trillion) last year.

While the market share of Celltrion’s existing autoimmune and oncology treatment product lines continues to grow steadily, the company expects its competitiveness in the Oceania market to be further strengthened through the approval of these three biosimilar products. In particular, Celltrion plans to solidify its market position by expanding treatment areas with follow-up pipelines such as ophthalmic and bone disease treatments.

Currently, the products that Celltrion is either selling or has received approval for in Australia include a total of 11 items: Ramcima, RamcimaSC, Uplyma, Stekima, Herzuma, Truxima, Vegzelma, Omriclo, IdenZelt, Stovoclo, and Osenbelt.

A Celltrion representative stated, "With the consecutive approvals of Celltrion products, the company’s competitiveness and influence in the biosimilar-friendly Oceania market are expected to be further enhanced. We plan to promptly complete the remaining commercialization procedures and do our best to ensure smooth supply of the products in the market."

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