Biocon Biologics Ltd., a fully integrated global biosimilars company and subsidiary of Biocon Ltd., has announced that it has reached a settlement and licensing agreement with Amgen Inc. This agreement allows for the U.S. commercialization of Bosaya (denosumab-kyqq) and Aukelso (denosumab-kyqq). The deal resolves ongoing patent issues in the U.S. District Court for the District of New Jersey, enabling Biocon Biologics to start the U.S. launch of both products on October 1, 2025. Several terms of the agreement remain confidential.
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Bosaya is formulated as a 60 mg/mL injection in a single-dose prefilled syringe, while Aukelso is available as 120 mg in 1.7 mL (70 mg/mL) for subcutaneous use in a single-dose vial. These biosimilars correspond to Amgen’s Prolia and Xgeva, respectively, and are used for the treatment of osteoporosis and bone complications associated with cancer. The U.S. Food and Drug Administration has approved both products with provisional interchangeability status.
Shreehas Tambe, Chief Executive Officer & Managing Director of Biocon Biologics, stated that the settlement opens the door for their high-quality denosumab biosimilars to reach U.S. patients and healthcare providers. He added that this move not only enhances their oncology portfolio but also marks their entry into bone health therapies. He highlighted that by expanding access to advanced biologic treatments, Biocon Biologics reaffirms its leadership in the biosimilars industry worldwide.
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Clinical trials have shown that Bosaya and Aukelso match the reference biologics in terms of safety, effectiveness, and quality. Bosaya follows the same Risk Evaluation and Mitigation Strategy (REMS) as Prolia, providing healthcare providers and patients—with particular attention to those with advanced chronic kidney disease—with information on risks such as severe hypocalcemia.
Osteoporosis is a long-term condition that weakens bones, increasing the risk of fractures. In the U.S., approximately 10 million adults over the age of 50 have osteoporosis, and another 44 million have low bone density, putting them at higher risk. Among people over 50, about half of women and one in four men will experience a bone fracture in their lifetime. Bone metastasis from advanced cancers affects more than 330,000 U.S. patients each year, leading to serious skeletal complications that can lower quality of life and increase healthcare costs. Giant cell tumor of bone is a rare but aggressive benign tumor typically found in young adults. Although not cancerous, it can cause pain, fractures, and disability, requiring medical care.
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