China-based Luye Pharma Group (HKG: 2186) has announced the first prescription of its biosimilar version of Amgen’s (NASDAQ: AMGN) Xgeva (denosumab), known as LY06006/BA6101, in Shandong, Jiangsu, Hunan, Tianjin, Shaanxi, and Jilin provinces. The drug was launched just 21 days after receiving marketing approval, marking a rapid entry into the market.
Product Approval and Indications
LY06006/BA6101 is approved for the treatment of osteoporosis in postmenopausal women at high risk of fracture. Denosumab, a novel RANKL inhibitor developed by Amgen and marketed in China by BeiGene, is known for its high affinity and specificity for the soluble and transmembrane forms of human RANKL. The 120mg dosage form of denosumab, sold under the trade name Xgeva, was approved in China in May 2019 for use in adults and adolescents with mature skeletal development and inoperable giant cell tumor of bone. The 60mg dosage form, sold under the trade name Prolia, was approved in June 2020 for treating bone loss in at-risk patients.
Global Expansion Plans
Luye Pharma’s LY06006/BA6101, the world’s first Prolia biosimilar, is also being prepared for clinical and market filings in Europe and the United States. This move underscores the company’s commitment to expanding its global presence and providing accessible treatment options for osteoporosis and related conditions.-Fineline Info & Tech
