What's Happening?
Biocon Biologics Ltd., a global biosimilars company, has announced a settlement and license agreement with Amgen Inc., allowing the commercialization of Bosaya™ and Aukelso™ in the United States. These biosimilars are alternatives to Amgen's Prolia® and Xgeva®, used for treating osteoporosis and cancer-related bone conditions. The agreement resolves pending patent litigation, enabling Biocon Biologics to launch these products in the U.S. starting October 1, 2025. The U.S. FDA approved these biosimilars in September 2025, granting provisional interchangeability designation. Bosaya™ is approved for various osteoporosis treatments, while Aukelso™ is approved for preventing skeletal-related events in cancer patients. Clinical data shows both biosimilars have comparable quality, safety, and efficacy to their reference products.
Why It's Important?
The entry of Biocon Biologics into the U.S. market with denosumab biosimilars represents a significant development in the treatment of osteoporosis and cancer-related bone conditions. This move is expected to enhance competition in the biosimilars market, potentially lowering costs and increasing access to advanced biologic medicines for patients. With osteoporosis affecting millions in the U.S., and bone metastases being a common complication of advanced cancer, these biosimilars could play a crucial role in improving patient outcomes and reducing healthcare burdens. Biocon Biologics' expansion into the bone health space underscores its commitment to broadening access to life-changing biologics.
What's Next?
Biocon Biologics is set to launch Bosaya™ and Aukelso™ in the U.S. from October 1, 2025. The company will focus on expanding access to these biosimilars, potentially influencing market dynamics and patient care standards. Healthcare providers and patients will need to be informed about the risks associated with these treatments, particularly severe hypocalcemia in patients with advanced chronic kidney disease. Biocon Biologics will likely continue to leverage its global scale manufacturing capabilities and innovative tech platforms to further penetrate the U.S. market and enhance its biosimilars portfolio.
