Biocon is commercially launching two biosimilars, Aukelso and Bosaya (both denosumab-kyqq) in the United States. Aukelso is a biosimilar to Xgeva, and Bosaya is a biosimilar to Prolia, both Amgen products.

Aukelso and Bosaya Background

The U.S. FDA granted interchangeable designations to both Aukelso and Bosaya in September 2025, permitting substitution at the pharmacy level. Aukelso and Bosaya are now available by prescription through specialty pharmacies—in accordance with state laws—and healthcare providers.

Both are available in their most common presentations. For Aukelso, that means a 120 mg/1.7 mL (70 mg/mL) injection for subcutaneous use, in a single-dose vial. Bosaya, comparatively, is available in a 60 mg/mL injection for subcutaneous use in a prefilled syringe.

Denosumab Crucial to Bone Health

The importance of the approval of these biosimilars is that denosumab products have a critical part in encouraging bone health. The products most commonly treat osteoporosis and cancer-associated bone complications, and in 2024 generated $5 billion in U.S. sales.

That dovetails with statistics revealing approximately 10 million adults over age 50 in the U.S. are estimated to have osteoporosis. Another 44 million are at risk due to low bone density.

Additionally, bone metastases are often a complication of advanced cancers, affecting more than 330,000 U.S. patients each year.

New Biocon CEO Reacts

Biocon CEO and Managing Director Shreehas Tambe said the biosimilars build on the company’s established leadership in oncology and immunology.

As previously reported, Tambe just recently assumed those leadership posts for Biocon Limited. He had served in the same capacities for Biocon Biologics prior to its integration as a wholly owned subsidiary.

“The U.S. introduction of Bosaya and Aukelso marks a strategic expansion of our biosimilars portfolio,” Tambe said. “These therapies broaden access to high‑quality, affordable treatment options for patients living with serious bone conditions.”