After successfully completing its review, the U.S. Food and Drug Administration (FDA) has granted approval to two new denosumab biosimilars from Biocon Biologics a prominent global biosimilars company. The newly approved products are Bosaya™ and Aukelso™. This marks a significant milestone in BBL's mission to expand access to more affordable biologic therapies. Both biosimilars have also been granted a provisional interchangeability designation by the FDA. a prominent global biosimilars company. The newly approved products are Bosaya™ and Aukelso™. This marks a significant milestone in BBL's mission to expand access to more affordable biologic therapies. Both biosimilars have also been granted a provisional interchangeability designation by the FDA.

Bosaya™ (denosumab-kyqq), a biosimilar of Prolia®, is approved for the treatment of various osteoporosis conditions in both men and women, as well as for increasing bone mass in patients receiving hormone ablation therapies for prostate and breast cancer. Aukelso™ (denosumab-kyqq), the biosimilar of Xgeva®, is approved for a range of oncological uses, including the prevention of skeletal-related events in patients with multiple myeloma and bone metastases from solid tumors, the treatment of giant cell tumor of bone, and the management of hypercalcemia of malignancy.

According to the company's CEO, Shreehas Tambe, this dual approval highlights BBL's strong scientific and regulatory capabilities and their commitment to providing high-quality, cost-effective biosimilars that support sustainable healthcare systems. The approvals are particularly significant given that the reference products, Prolia® and Xgeva®, generated nearly $5 billion in U.S. sales last year. Clinical data demonstrated that both Bosaya™ and Aukelso™ have comparable quality, safety, and efficacy to their respective reference products. As with the originals, both biosimilars carry a Risk Evaluation and Mitigation Strategy (REMS) and a boxed warning about the risk of severe hypocalcemia, particularly in patients with advanced chronic kidney disease.

Denosumab, the active ingredient in these products, is a human monoclonal antibody that targets and binds to RANKL, a protein crucial for bone breakdown. By blocking this pathway, denosumab helps to increase bone mass and strength. The approval of these biosimilars addresses significant public health needs, as conditions like osteoporosis, which affects millions of adults in the U.S., and bone metastases, a common complication of advanced cancer, pose a substantial healthcare burden. Biocon Biologics, through these and other pipeline assets, continues to leverage its comprehensive "lab to market" capabilities to provide affordable access to critical therapies for patients worldwide.