Celltrion Pharm Announces Domestic Sales of Bone Disease Treatments 'Stovoclo' and 'Osenbelt'

First Domestic Sales of Prolia and Xgeva Biosimilars Begin

Exterior view of Celltrion Pharm factory in Cheongju, Chungbuk. Photo by Celltrion Pharm

Celltrion Pharm announced on the 18th that it will officially begin the domestic sales process for the biosimilars of the bone disease treatments 'Prolia·Xgeva (active ingredient Denosumab)', named 'Stoboclo·Osenbelt'.

Stoboclo is a treatment with indications for postmenopausal osteoporosis in women and increasing bone density in men, while Osenbelt is indicated for the prevention of skeletal-related complications due to bone metastases in cancer patients and giant cell tumor of bone, both containing the same active ingredient. According to IQVIA, a pharmaceutical market research firm, in South Korea, Prolia had a market size of approximately 151.1 billion KRW and Xgeva about 10.5 billion KRW in 2023, forming a total market of around 161.6 billion KRW.

Stoboclo and Osenbelt recently received product approvals consecutively in major countries such as Europe and the United States, and domestically, they secured the 'First Mover' status by obtaining the Ministry of Food and Drug Safety's product approval last November as the first biosimilars containing denosumab.

Subsequently, through the Health and Welfare Ministry's insurance price listing process, 'Stoboclo Prefilled Syringe 60mg/1ml' and 'Osenbelt Injection 0.12g/1.7ml' were priced at 111,384 KRW and 175,972 KRW respectively. With this, the products will be launched domestically, enabling them to capture the market ahead of competing biosimilar products.

Notably, Stoboclo features an improved syringe design compared to existing products, enhancing convenience and safety for medical professionals. The syringe is designed so that the needle automatically retracts into the body after injection. It allows for easy one-handed injection and disposal, minimizing the risk of needle injuries. The cap covering the needle contains no latex, making it safe for sensitive patients to use with confidence.

Additionally, after separate stability testing, the shelf life from the manufacturing date was extended by 12 months compared to competing products, reaching 48 months. At room temperature, the shelf life is doubled to 30 days compared to 14 days for competing products, securing differentiation.

A Celltrion Pharm representative stated, "Through the domestic sales of Stoboclo and Osenbelt, we will expand our treatment portfolio into various areas including allergy diseases, ophthalmic diseases, and bone diseases, following our existing autoimmune disease treatments and anticancer drugs, thereby strengthening our market competitiveness. Leveraging the advantage of being a first mover, we will rapidly target the approximately 160 billion KRW domestic market and do our best to ensure these products quickly establish themselves in the market."