Celltrion announced on the 10th that it received item approval from the Therapeutic Goods Administration (TGA) of Australia for its ophthalmic treatment 'Eydenzelt' (ingredient name: Aflibercept) and the bone disease treatments 'Stoboclo' and 'Osenvelt' (Denosumab).
'Eydenzelt' is a biosimilar of Regeneron's Eylea and is approved for the treatment of myopic choroidal neovascularization. The approved formulations include injectable and prefilled syringe (PFS) versions. It is the first Aflibercept biosimilar approved in Australia, and the company expects to gain a competitive edge in the market. The original drug, Eylea, recorded global sales of $9.523 billion (13.33 trillion won) last year.
'Stoboclo' is a biosimilar of Amgen's Prolia and is approved for postmenopausal women with osteoporosis. Similarly, 'Osenvelt', a biosimilar of Amgen's Xgeva, received approval for preventing skeletal-related complications in patients with bone metastatic cancer and all other treatment indications held by the original drug in Australia.
The original products of 'Stoboclo' and 'Osenvelt', Prolia and Xgeva, had combined global sales of approximately $6.599 billion (9.2 trillion won) last year.
Celltrion expects that the approval of these three biosimilars will significantly enhance its competitiveness in the Oceania market. The products currently sold or approved by Celltrion in Australia include autoimmune disease treatments such as Remsima, Remsima SC, Uplyma, and Steqeyma, as well as anticancer drugs like Herzuma, Truxima, and the allergy disease treatment Omnicluda. With the addition of Eydenzelt and Stoboclo-Osenvelt, a total of 11 products have been approved.
A Celltrion official noted, "With the consecutive approvals, the company's competitiveness and influence in the biosimilar-friendly Oceania market are expected to be further strengthened. We will do our best to promptly complete the remaining commercialization procedures and ensure that the products can be smoothly supplied in the market."