Daewoong Pharmaceutical officially launched Celltrion Pharm's osteoporosis treatment Prolia biosimilar, "Stoboclo," in the domestic market on the 19th. Stoboclo is the first domestic biosimilar of Prolia.
Prolia (ingredient name denosumab), developed by Amgen in the United States, blocks the activity of osteoclasts that destroy bone, preventing bone resorption and increasing bone density. It reduces the risk of bone loss and fractures in postmenopausal women and suppresses bone metastasis in cancer patients, helping to mitigate complications.
Stoboclo maintains its effectiveness for six months with a single injection. Compared to other treatments requiring administration every 1 to 3 months, it exhibits a higher rate of patient compliance with expert prescription instructions. Patients can reduce hospital visits, and the burden of medication management on healthcare professionals can also be expected to decrease. Global Phase 3 clinical study results have demonstrated its equivalency to the original drug.
The syringe design, which has been significantly improved compared to existing products, enhances both the convenience and safety for healthcare professionals. Particularly, it is designed so that the needle automatically retracts into the body after injection, allowing easy post-injection handling with one hand. The risk of injury from needles has also been minimized. The cap covering the needle contains no latex, enabling sensitive patients to use it with confidence. Stoboclo is priced 28% lower than the original drug, increasing treatment accessibility for patients.
Celltrion received the first domestic approval from the Ministry of Food and Drug Safety last November for the Prolia biosimilar, Stoboclo. In February, it also obtained product approval from the European Commission (EC) and the U.S. Food and Drug Administration (FDA).
According to a contract previously signed, Daewoong Pharmaceutical will jointly sell Stoboclo at general hospitals and clinics nationwide in collaboration with Celltrion Pharm. Celltrion Pharm has secured product quality and efficacy based on its capabilities in biosimilar development and global clinical trials, while Daewoong Pharmaceutical plans to actively expand the product's market presence in South Korea by leveraging its strong sales and marketing network.
You Young-ho, CEO of Celltrion Pharm, said, "Stoboclo will be an important alternative that provides equivalent effectiveness and safety to Prolia while reducing the treatment burden for patients." Lee Chang-jae, CEO of Daewoong Pharmaceutical, noted, "Daewoong Pharmaceutical will maximize market competitiveness through a differentiated 'validated four-step' marketing strategy and objectively prove the reliability of the product, thereby strengthening its position in the biopharmaceutical market."