Boan Biotech files two denosumab injections for UK approval

Boan Biotech announced that the Marketing Authorization Applications (MAAs) for its self-developed denosumab injections—the 60 mg BA6101 for orthopedic conditions and the 120 mg BA1102 for oncology—have been accepted by the UK Medicines and Healthcare products Regulatory Agency (MHRA).

BA6101 is a biosimilar to Prolia®. It gained approval in China in 2022 as the first China-developed denosumab injection and has since garnered positive feedback from physicians and patients through nearly three years of clinical application. BA1102 is a biosimilar to Xgeva® and was approved in China in 2024. 

BA6101 and BA1102 are core products developed by Boan Biotech based on its global development strategy. The company is actively promoting the international clinical trials and registration of these two products. In addition to the UK, the company will also submit marketing applications for these two products to international pharmaceutical regulatory agencies such as the European Medicines Agency (EMA), the US Food and Drug Administration (FDA), and Japan's Pharmaceuticals and Medical Devices Agency (PMDA).

Based on extensive clinical needs and excellent clinical value, denosumab presents broad market prospects globally. Public data shows that the combined global sales of Prolia® and Xgeva® reached approximately USD 6.6 billion in 2024. To support global commercialization goals, Boan Biotech has established a comprehensive quality management system that complies with relevant standards in China, Europe, the U.S., and Japan, providing quality assurance for the successful international expansion of denosumab and subsequent biologics.