Biosimilar drug of diabetic bone pine has applied for Japanese drug license and will be on the market by the end of 2027 at the earliest

Taiwan Sugar Association (4168), a new drug company, announced today that the osteoporosis biosimilar drug SPD8 (Denosumab) jointly developed with Japan's Mitsubishi Gas Chemical (MGC) has officially submitted a manufacturing and sales approval application (drug inspection registration) to Japan's Pharmaceuticals and Medical Devices Agency (PMDA). Depending on the PMDA review results, it is expected to be approved by Japan as soon as the end of 2027, and will be launched after the Japanese National Health Insurance Drug Price is included. At the same time, preparations for drug license applications in the Taiwan market are also under way.

Tanglian said that SPD8 has attracted negotiations with pharmaceutical companies from Asia, the Middle East, Central and South America and other countries, and Sugarlian is promoting commercialization in the global market at full speed. Tanglian owns all sales, distribution and commercialization rights around the world except Japan, and continues to seek regional partners. Japan is a reference country for drug license applications in Taiwan and many other countries. Obtaining a Japanese drug license will have the opportunity to speed up the drug license review by regulatory authorities in other countries.

SPD8’s reference original drug Denosumab is a widely used osteoporosis treatment drug with sales of US$6.5 billion in 2025.

Yang Meijun, general manager of SugarLink, said: "Formally filing an application for Japanese PMDA manufacturing and sales recognition is a major milestone for SugarLink to move towards global commercialization. SPD8 is expected to bring a stable source of income. With the experience of SPD8, we can accelerate the development plan of the second biosimilar drug SSR. The experience of promoting the launch of biologic drugs will also be of great help to the development of new drugs."