China-based Mabwell (Shanghai) Bioscience Co., Ltd (SHA: 688062) has announced receiving market approval from the National Medical Products Administration (NMPA) for its biosimilar version of US major Amgen’s Prolia (denosumab). This development marks Mabwell’s drug as the world’s second biosimilar of Prolia, which is used to treat osteoporosis in postmenopausal women at high risk of fractures.
Denosumab’s Impact and Mabwell’s Biosimilar Offering
Denosumab, a novel RANKL inhibitor originated by Amgen, is currently marketed in China by BeiGene. It has been recognized for its ability to significantly reduce the risk of multiple fractures in patients, including vertebral, non-vertebral, and hip fractures. Mabwell’s biosimilar offers a pre-filled syringe and a long-term medication regimen of subcutaneous injection once every six months, enhancing convenience and patient compliance with self-treatment. The safety data for denosumab spans 10 years of clinical application, making it a superior treatment option for long-term management.
Market Potential and Sales Performance of Prolia
Prolia brought in USD 3.628 billion in 2022 sales for Amgen, marking a 12% year-on-year (YOY) increase. Its Japanese-licensed version, Pralia, generated JPY 37.9 billion (USD 283.8 million) in 2021. The market for denosumab in China is projected to be worth RMB 7.8 billion (USD 1.1 billion) by 2030, indicating significant growth potential for this treatment in the country.-Fineline Info & Tech
