China-based Luye Pharma Group (HKG: 2186) has announced that a market approval filing for its subsidiary Shandong Boan Biotechnology Co., Ltd’s BA1102, a biosimilar version of Amgen’s (NASDAQ: AMGN) Xgeva (denosumab), has been accepted for review by the Center for Drug Evaluation (CDE).
Indications and Market Context
Denosumab is a monoclonal antibody with high affinity and specificity for the soluble, transmembrane form of human RANKL. It is used to treat patients with solid tumor bone metastasis or multiple myeloma to delay or reduce the risk of bone-related events, such as pathological fractures, spinal cord compression, bone radiotherapy, or bone surgery. It is also indicated for adults and adolescents with mature skeletal development who have inoperable giant cell tumor of bone or surgically removed giant cell tumors that may cause severe dysfunction.
Market Presence and Biosimilar Development
Denosumab, a novel RANKL inhibitor originated by Amgen, is currently marketed in China by BeiGene. The 120mg dosage form, under the trade name Xgeva, was approved in China in May 2019, and the 60mg dosage form, sold as Prolia for osteoporosis, was approved in June 2020. Luye Pharma’s LY06006/BA6101, a biosimilar version of Prolia, received market approval in November last year. Other companies, including Qilu Pharma, Alphamab Oncology, and Henlius Pharma, are also developing denosumab biosimilars. BA1102 has the potential to become the first biosimilar version of Xgeva in China.-Fineline Info & Tech
