Celltrion wins Australian approval for eye, bone disease biosimilars

Celltrion Inc. said Wednesday it has received regulatory approval from Australia’s Therapeutic Goods Administration (TGA) for three biosimilars: Eydenzelt, a treatment for eye diseases; and Stoboclo and Osenvelt, targeting bone diseases.

Eydenzelt, referencing Eylea, can be administered in two formulations: vial injection and pre-filled syringe (PFS).

Stoboclo and Osenvelt reference Prolia and Xgeva, respectively. Stoboclo was approved for treating postmenopausal osteoporosis.

The two biosimilar products received clearance for all indications covered by their originator drugs in Australia, including prevention of skeletal-related events in patients with bone metastases and treatment of giant cell tumors of bone.

“The approval of the biosimilars will strengthen our competitiveness and influence in the biosimilar-friendly Oceania market,” said a Celltrion official.


Yeonhee Kim edited this article.