Daewoong Pharmaceutical Launches Denosumab Biosimilar 'Stoboclo'... Targeting Osteoporosis Market

The First Domestically Launched Denosumab Biosimilar

Daewoong Pharmaceutical announced on the 19th that it has officially launched Celltrion Pharmaceutical's osteoporosis treatment 'Stovoclo' in the domestic market.

Lee Chang-jae, CEO of Daewoong Pharmaceutical (right), and Yoo Young-ho, CEO of Celltrion Pharmaceutical, are posing for a commemorative photo after signing a joint sales agreement for the osteoporosis treatment CT-P41 (Stovoclo) at Celltrion Pharmaceutical's Seoul office in Songpa-gu, Seoul, on October 30 last year. Daewoong Pharmaceutical

Stovoclo is the first domestic biosimilar of the global blockbuster drug 'Prolia.' It inhibits the activity of osteoclasts that destroy bones, preventing bone resorption and increasing bone density. Through this, it helps prevent bone loss in postmenopausal women, reduces the risk of fractures, and in cancer patients, it suppresses bone metastasis and protects bone structure, thereby reducing complications.

Since Stovoclo maintains its effect for six months with a single injection, it has higher medication adherence compared to other treatments that require administration every one week to three months. Accordingly, it can reduce the treatment burden on patients and the number of hospital visits, and it is expected to alleviate the medication management burden on healthcare providers as well. Global Phase 3 clinical trial results have demonstrated equivalence to the original drug.

Additionally, Stovoclo applies an improved syringe design compared to existing products, enhancing convenience and safety for healthcare professionals. In particular, it is designed so that the needle automatically retracts into the body after injection. This allows for easy post-injection handling with one hand and minimizes the risk of needle-related injuries. Furthermore, the cap covering the needle does not contain latex, allowing sensitive patients to use it with confidence.

Stovoclo is expected to contribute to reducing patients' economic burden by being priced 28% lower than the original drug, while also improving treatment accessibility.

Celltrion obtained domestic approval from the Ministry of Food and Drug Safety (MFDS) for Stovoclo last November as the first mover among biosimilars with the same active ingredient. Subsequently, last month, it secured approvals from the European Commission (EC) and the U.S. Food and Drug Administration (FDA), laying the foundation for entry into the global market.

According to a previously signed agreement, Daewoong Pharmaceutical will jointly market Stovoclo nationwide in general hospitals and clinics together with Celltrion Pharmaceutical. Celltrion Pharmaceutical has secured product quality and efficacy based on its biosimilar development and global clinical capabilities, while Daewoong Pharmaceutical plans to actively expand the product’s presence in the domestic market by leveraging its strong sales and marketing network.

Yoo Young-ho, CEO of Celltrion Pharmaceutical, said, "Stovoclo will be an important alternative that provides equivalent efficacy and safety to the original drug while reducing the treatment burden on patients. As the first mover among biosimilars with the same active ingredient, we will do our best to quickly establish the product in the market based on the market preemption effect and product competitiveness."

Lee Chang-jae, CEO of Daewoong Pharmaceutical, stated, "Daewoong Pharmaceutical will maximize market competitiveness through a differentiated four-step verified marketing strategy and objectively prove the reliability of the product to strengthen its position in the biopharmaceutical market. Through the domestic launch of Stovoclo, we will ensure that more patients can benefit from treatment and strive to make it a long-term osteoporosis treatment option."

This content was produced with the assistance of AI translation services.