Biocon Biologics, a subsidiary of Biocon, has launched its denosumab biosimilars—Bosaya and Aukelso—in the US market, marking an important milestone in the company’s global expansion journey.
The launch comes after approval from the U.S. Food and Drug Administration (FDA approval) in September 2025. The two products are biosimilars to Amgen’s widely used drugs, Prolia and Xgeva, which are prescribed for treating osteoporosis treatment needs and cancer-related bone conditions.
Bosaya is designed for patients suffering from osteoporosis who are at a high risk of fractures, while Aukelso is used to prevent bone complications in cancer patients, especially those with bone metastases therapy requirements. Both medicines have shown similar safety, quality, and effectiveness compared to their reference drugs, making them reliable alternatives for patients in the growing biosimilars US segment.
The US launch was made possible through a settlement and licensing agreement with Amgen, which resolved patent-related issues. This agreement allowed Biocon Biologics to enter the market starting October 2025, strengthening its position in the affordable biologics space.
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Another key advantage for Bosaya and Aukelso is their provisional interchangeable biosimilars status granted by the FDA. This means pharmacists may substitute these biosimilars for the original products without needing approval from doctors, depending on state laws, improving access and adoption.
With this move, Biocon Biologics reinforces its presence in oncology and bone health while advancing its mission to expand access to cost-effective treatments. The launch also highlights the growing importance of Amgen Prolia Xgeva alternatives in reducing healthcare costs globally.
As demand for affordable therapies rises, the company is well-positioned to expand its footprint and compete strongly in the global biosimilars market.
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