[News Space=Reporter seungwon lee] Celltrion announced on the 10th that it recently received approval for the eye disease treatment 'Idenselt (ingredient: aflibercept)' and the bone disease treatment 'Stoboclo-Osenvelt (ingredient: denosumab)' from the Australian Therapeutic Goods Administration (TGA). It has received approval for a total of three biosimilars in the past two weeks.

Idenselt has been approved for the indication of myopic choroidal neovascularization (myopic CNV). The approved formulations are injectable (vial) and prefilled syringe (PFS).

Celltrion expects that Idengelt will be the first biosimilar to receive approval in Australia, and that it will quickly penetrate the market by taking the lead in the early market with the status of a ‘first mover.’ Idengelt’s original drug, Eylea, is a blockbuster ophthalmic disease treatment that achieved global sales of USD 9.523 billion (approximately KRW 13.3322 trillion) last year.[1]

Stoboclo has been approved for all indications for which the original medicine had been approved in Australia, including osteoporosis in postmenopausal women, and Osenvelt for preventing skeletal complications in patients with bone metastases and giant cell tumor of bone.

Prolia and Xgiva, the original products of Stoboclo and Osenvelt, had combined global annual sales of approximately $6.599 billion (KRW 9.2 trillion) last year.

Celltrion expects that its competitiveness in the Oceania market will be further strengthened through the approval of three biosimilars, as its existing autoimmune disease and anticancer treatment product lines show steady growth in market share. In particular, it plans to further solidify its position in the market with a follow-up pipeline that expands treatment areas to include ophthalmic and bone disease treatments.

Celltrion currently has 11 products sold or approved in Australia: ▲Remsima, Remsima SC, Uplyma, Stekima (all autoimmune disease treatments); ▲Herzuma, Truxima, Vegelma (all anticancer drugs); ▲Omriclor (allergic disease treatment); ▲Idenselt (ophthalmic disease treatment); ▲Stovoclo-Osenvelt (bone disease treatment).

A Celltrion official said, “With the successive approvals for Celltrion products, the company’s competitiveness and influence in the Oceania market, which is friendly to biosimilars, is expected to be further strengthened,” adding, “We will do our best to quickly complete the remaining commercialization procedures and ensure that the products are supplied smoothly in the market.”