On May 29, 2026, Boan Biotech announced that it submitted a Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA) for BA6101 (denosumab; injection 60 mg) and BA1102 (denosumab; injection 120 mg), referencing Amgen’s PROLIA® (denosumab) and XGEVA® (denosumab), respectively.
According to Boan Biotech, the submission is intended to support commercialization of the products in the United States and overall, advance international expansion and promotion of its denosumab biosimilars.
Denosumab is a RANKL inhibitor and is used in the treatment of bone-related disorders, including osteoporosis and bone metastases from certain cancers. The BLA submitted by Boan Biotech seeks approval for all indications currently approved for the two reference drug products: BA6101 for the treatment of conditions related to osteoporosis, and BA1102 for the treatment of conditions related to bone metastases from solid tumors, multiple myeloma, giant cell tumor of bone, and hypercalcemia of malignancy.
Currently, ten other companies have an FDA-approved denosumab biosimilar product, seven of which have a denosumab biosimilar commercially available in the United States.