Biocon Biologics secures USFDA approval for Bosaya and Aukelso biosimilars

Biocon Biologics gets USFDA approval for Bosaya and Aukelso, denosumab biosimilars of Prolia and Xgeva, with provisional interchangeability status to widen patient access

Biocon Biologics on Wednesday got the US Food and Drug Administration (FDA) approval for its two denosumab biosimilars, Bosaya (denosumab-kyqq) 60 mg/mL injection and Aukelso (denosumab-kyqq) 120 mg/1.7 mL (70 mg/mL) injection, biosimilars of Prolia and Xgeva, respectively, with the FDA also conferring provisional interchangeability status on both medicines, the company said in a filing.

 

Treatment scope for Bosaya

 

Bosaya has been approved for a wide range of osteoporosis-related conditions. It can be used in postmenopausal women with osteoporosis who are at high risk of fractures and in men with osteoporosis at similar risk. It is also indicated for men and women with glucocorticoid-induced osteoporosis, again where fracture risk is high.

 

 

Beyond this, Bosaya can be prescribed to men receiving androgen deprivation therapy for non-metastatic prostate cancer and to women undergoing adjuvant aromatase inhibitor therapy for breast cancer, both groups being at increased risk of bone loss.

 

Treatment scope for Aukelso

 

Aukelso has been cleared for use in oncology and other serious bone-related conditions. It is approved to help prevent skeletal complications in patients with multiple myeloma or bone metastases from solid tumours.

 

It is also suitable for adults and skeletally mature adolescents with giant cell tumour of bone (GCTB) that cannot be removed surgically or where surgery could result in serious complications. In addition, it can be used for hypercalcaemia of malignancy that does not respond to bisphosphonate treatment.

 

Commenting on the development, Shreehas Tambe, CEO & managing director, Biocon Biologics, said, “The FDA’s approval of Bosaya and Aukelso is a significant milestone in our mission to expand access to critical biologic therapies. With Bosaya, we are proud to offer a more affordable treatment option for patients with osteoporosis, and with Aukelso, we are further expanding our oncology care portfolio. This achievement underscores our scientific and regulatory capabilities and reinforces our commitment to delivering high-quality biosimilars that support sustainable healthcare systems and improve patient outcomes.”

 

Safety and clinical evidence

 

Data from clinical trials showed that both biosimilars matched their reference medicines in quality, safety, and efficacy. Bosaya carries the same Risk Evaluation and Mitigation Strategy (REMS) programme as Prolia. This includes warnings for doctors and patients about the risk of severe hypocalcaemia in people with advanced chronic kidney disease (CKD), including those who rely on dialysis.

 

Market impact

 

According to IQVIA National Sales Perspectives Data, denosumab generated close to $5 billion in US sales in 2024, with Prolia contributing $3.3 billion and Xgeva making up $1.6 billion.

 

Disease burden

 

Osteoporosis is a long-term condition that weakens bones, making them brittle and more likely to break. In the United States, around 10 million adults over the age of 50 are estimated to be living with osteoporosis, while a further 44 million are at risk due to low bone density. Research suggests that one in two women and one in four men over 50 will suffer a fracture during their lifetime as a result of osteoporosis, the company added.

 

Bone metastases, which occur when cancer spreads to the bone, are another serious health challenge, affecting over 330,000 patients every year in the US. These complications can cause significant pain, reduce quality of life, and place a heavy burden on healthcare resources.

 

Meanwhile, giant cell tumour of bone (GCTB), though rare and non-cancerous, is a locally aggressive condition that mainly affects young adults. It can result in severe pain, fractures, and long-term disability, underlining the importance of effective treatment options.