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Biocon Biologics Secures U.S. Market Entry Date for Bosaya and Aukelso, Denosumab Biosimilars

October 1, 2025 – Logistics, Other, Pharmaceutical – Amgen, Biocon, Biocon Biologics, biosimilars, license agreement, oesteoporosis

1 October 2025 — Bengaluru, India and New Jersey, US — Biocon Biologics Ltd, a fully integrated global biosimilars company and subsidiary of Biocon Ltd, today announced a settlement and license agreement with Amgen Inc. that clears the path for the commercialization of Bosaya (denosumab-kyqq) and Aukelso (denosumab-kyqq) in the United States.

Bosaya 60 mg/mL injection in a single-dose prefilled syringe (PFS) and Aukelso 120 mg/1.7 mL (70 mg/mL injection for subcutaneous use in a single-dose vial, are biosimilars to Amgen’s Prolia and Xgeva, respectively. These products are used in the treatment of osteoporosis and cancer-related bone conditions.

Biocon Biologics and Amgen executed the settlement agreement to resolve the pending patent litigation at the United States District Court for the District of New Jersey.

The agreement enables Biocon Biologics to launch BOSAYA and AUKELSO in the U.S. from October 1, 2025. The other terms of the settlement remain confidential.

Shreehas Tambe, CEO & Managing Director, Biocon Biologics, said, “This settlement paves the way for Biocon Biologics to bring our high-quality denosumab biosimilars, Aukelso and Bosaya, to patients and healthcare providers in the United States. These therapies will not only strengthen our oncology portfolio but also mark our entry into the bone health space—an important step as we continue to broaden access to life-changing biologics for patients across therapeutic areas. By expanding access to advanced biologic medicines, we are reaffirming our role as a global biosimilar leader.”

The U.S. Food and Drug Administration (FDA) had approved BOSAYA and AUKELSO in September 2025. In addition, the U.S. FDA granted provisional interchangeability designation for both BOSAYA and AUKELSO.

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 nonmetastatic prostate cancer, and to increase bone mass in women at high risk for fracture receiving adjuvant aromatase inhibitor therapy for breast cancer.

AUKELSO is approved for the prevention of skeletal-related events in patients with multiple myeloma and in patients with bone metastases from solid tumors, to treat adults and skeletally mature adolescents with giant cell tumor of bone that is unresectable or where surgical resection is likely to result in severe morbidity, and to treat hypercalcemia of malignancy refractory to bisphosphonate therapy.

Clinical data showed that both biosimilars demonstrated comparable quality, safety, and efficacy to the reference product. BOSAYA is approved with the same Risk Evaluation and Mitigation Strategy (REMS) plan as PROLIA to likewise inform healthcare providers and patients of the risks of severe hypocalcemia in patients with advanced chronic kidney disease (CKD), including dialysis-dependent patients, associated with BOSAYA.

About Biocon Biologics
Biocon Biologics, a subsidiary of Biocon Limited, is a unique, fully integrated, global biosimilars company committed to transforming healthcare and transforming lives. It is capitalizing on its ‘lab to market’ capabilities to serve over 6.0 million patients across 120+ countries by enabling affordable access to high quality biosimilars. The Company is leveraging cutting-edge science, innovative tech platforms, global scale manufacturing capabilities and world-class quality systems to lower costs of biological therapeutics while improving healthcare outcomes. Biocon Biologics has commercialized 10 biosimilars from its portfolio which are addressing the patients’ needs in key emerging markets and advanced markets like U.S., Europe, Australia, Canada, and Japan. It has a pipeline of 20 biosimilar assets across diabetology, oncology, immunology, ophthalmology, bone health and other non-communicable diseases. The Company has many ‘firsts’ to its credit in the biosimilars industry. As part of its environmental, social and governance (ESG) commitment, it is advancing the health of patients, people, and the planet to achieve key UN Sustainable Development Goals (SDGs). The meaningful progress on ESG parameters has been recognized with the Company’s inclusion in the S&P Global Sustainability Yearbook in 2025. Website: www.bioconbiologics.com.

About Biocon
Biocon, publicly listed in 2004, is an innovation-led global biopharmaceuticals company committed to enhance affordable access to complex therapies for chronic conditions like diabetes, cancer and autoimmune. It has developed and commercialized novel biologics, biosimilars, and complex small molecule APIs in India and several key global markets as well as Generic Formulations in the US, Europe & key emerging markets. It also has a pipeline of promising novel assets in immunotherapy under development. Website: www.biocon.com.