Shares of Biocon Ltd were trading in the green and 2% on 18 September after the company’s subsidiary, Biocon Biologics, received approval from the US Food and Drug Administration (USFDA) 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.

These injections are biosimilars of Prolia and Xgeva, respectively, with the FDA also conferring provisional interchangeability status on both medicines, according to the company.

Bosaya has been licensed for a variety of osteoporosis-related disorders. It is suitable for postmenopausal women with osteoporosis who are at high risk of fractures, as well as males with osteoporosis who are at similar risk. It is also recommended for men and women with glucocorticoid-induced osteoporosis, where fracture risk is considerable.

Beyond that, Bosaya can be recommended to men receiving androgen deprivation therapy for non-metastatic prostate cancer and women receiving adjuvant aromatase inhibitor therapy for breast cancer, both of whom are at a higher risk of bone loss.

Aukelso is approved for the treatment of cancer and other serious bone-related disorders. It has been approved to help avoid skeletal problems in patients with multiple myeloma or bone metastases from solid tumours.

It is also appropriate for adults and skeletally mature adolescents with giant cell tumours of bone (GCTB) that cannot be medically removed or when surgery could cause major consequences. It can also be used to treat cancer-related hypercalcaemia 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.”

At 1:57 pm, the shares of Biocon were trading 3.07% higher at Rs 365.25 on NSE.

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