1 week Ago By Jung So-yeon
Celltrion announced on April 10 that it has received product approvals from the Australian Therapeutic Goods Administration (TGA) for the eye disease treatment Idencel (active ingredient: Aflibercept) and the bone disease treatment Strovaklo-Ocenbelt (active ingredient: Denosumab). This marks the company’s third biopharmaceutical approval in just two weeks. Idencel has been approved for the treatment of myopic choroidal neovascularization (myopic CNV), with the approved formulations available as both injectable vials and pre-filled syringes (PFS).
Celltrion anticipates that Idencel, being the first biosimilar to be approved for this indication in Australia, will secure a 'first mover' advantage, allowing for rapid market penetration. The original drug, Eylea, achieved global sales of $9.523 billion last year and is a blockbuster treatment for eye diseases.
Strovaklo, which targets postmenopausal osteoporosis in women, and Ocenbelt, aimed at preventing skeletal complications in cancer patients with bone metastases and giant cell tumors of the bone, have received approval for all indications held by their original drugs in Australia. The original products, Prolia and Xgeva, reported a combined global revenue of approximately $6.599 billion last year.
With steady growth in market share for its existing autoimmune disease and cancer treatment products, Celltrion expects to strengthen its competitive edge in the Oceania market through these three new biosimilar approvals. The company aims to solidify its position further by expanding its pipeline into therapeutic areas such as eye diseases and bone conditions. Currently, Celltrion has a total of 11 products being sold or approved in Australia, including ▲ Remsima, Remsima SC, Yuflyma, and Steqima (all autoimmune disease treatments) ▲ Herzuma, Truxima, and Vegzelma (all cancer treatments) ▲ Omrylco (allergy treatment) ▲ Idencel (eye disease treatment) and ▲ Strovaklo-Ocenbelt (bone disease treatment).
A Celltrion representative stated, “With the consecutive approvals of our products, we expect to strengthen our competitiveness and influence in the biosimilar-friendly Oceania market. We will strive to complete the remaining commercialization processes promptly to ensure a smooth supply of our products in the market.”.
