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Biocon Biologics Receives U.S. Food and Drug Administration Approval for Bosaya™ and Aukelso™, Denosumab Biosimilars
Biocon Biologics Ltd. (BBL), a fully integrated global biosimilars company and subsidiary of Biocon Ltd. (BSE: 532523, NSE: BIOCON), today announced that the U.S. Food and Drug Administration (FDA) has approved Bosaya™ (denosumab-kyqq) 60 mg/mL injection for subcutaneous use in a single dose prefilled syringe (PFS), and Aukelso™ (denosumab-kyqq) 120 mg/1.7 mL (70 mg/mL) injection for subcutaneous use in a single-dose vial, biosimilars of Prolia® and Xgeva® respectively. In addition, the U.S. FDA
About this update from Biocon Limited
[{"type":"text","content":"BENGALURU, India and BRIDGEWATER, N.J., Sept. 17, 2025 /PRNewswire/ -- Biocon Biologics Ltd. (BBL), a fully integrated global biosimilars company and subsidiary of Biocon Ltd. (BSE: 532523, NSE: BIOCON), today announced that the U.S. Food and Drug Administration (FDA) has approved Bosaya™ (denosumab-kyqq) 60 mg/mL injection for subcutaneous use in a single dose prefilled syringe (PFS), and Aukelso™ (denosumab-kyqq) 120 mg/1.7 mL (70 mg/mL) injection for subcutaneous use in a single-dose vial, biosimilars of Prolia® and Xgeva® respectively. In addition, the U.S. FDA granted provisional interchangeability designation for both BOSAYA and AUKELSO.","length":656,"tagName":"p"},{"type":"image","alt":"Biocon Biologics","displaySize":"","headline":null,"caption":"Biocon Biologics","className":"","disableSlideshowImg":false,"size":{"original":{"width":400,"height":250,"url":"https://media.zenfs.com/en/prnewswire.com/f52c945188fde03caec2c4e41e57e558"},"resized":{"url":"https://s.yimg.com/ny/api/res/1.2/dHzfawpfy0cFqQUi6PoEtQ--/YXBwaWQ9aGlnaGxhbmRlcjt3PTcwNTtoPTQ0MTtjZj13ZWJw/https://media.zenfs.com/en/prnewswire.com/f52c945188fde03caec2c4e41e57e558","width":400,"height":250}},"href":"https://mma.prnewswire.com/media/2775049/biocon_biologics_logo.html","hrefExternal":true,"rel":"nofollow"},{"type":"text","content":" Shreehas Tambe, CEO & Managing Director, Biocon Biologics, said, " The FDA's approval of Bosaya™ and Aukelso™ is a significant milestone in our mission to expand access to critical biologic therapies. With Bosaya™, we are proud to offer a more affordable treatment option for patients with osteoporosis, and with Aukelso™, we are further expanding our oncology care portfolio. This achievement underscores our scientific and regulatory capabilities and reinforces our commitment to delivering high-quality biosimilars that support sustainable healthcare systems and improve patient outcomes. "","length":618,"tagName":"p"},{"type":"text","content":"BOSAYA is approved for the treatment of postmenopausal women with osteoporosis at high risk for fracture, to increase bone mass in men with osteoporosis at high risk for fracture, glucocorticoid-induced osteoporosis in men and women at high risk for fracture, to increase bone mass in men at high risk for fracture receiving androgen deprivation therapy for nonmetas...