Biocon Biologics secures USFDA approval for Bosaya and Aukelso biosimilars to treat osteoporosis and bone loss

USFDA nod to Biocon’s Bosaya and Aukelso mark significant progress in making denosumab biosimilars widely available for osteoporosis, cancer, and bone disease patients.

Osteoporosis is a medical condition that makes bones weak and making them more susceptible for fractures. It mostly affects older people, especially women after menopause are at higher risk, but men can get it too. It happens when the body can't keep up with making new bone to replace old bone leading to less dense and weaker bones.

Some factors like old age, hormonal shifts, medications and lifestyle changes like not staying active or eating well can speed up bone loss. You might not know you have it until you get a fracture.

In a major milestone for the treatment of osteoporosis and bone loss, Biocon Biologics Ltd, a subsidiary of Biocon Ltd, on Wednesday has secured approval from the US Food and Drug Administration (USFDA) for two of its denosumab biosimilars — Bosaya (denosumab-kyqq) and Aukelso (denosumab-kyqq).

Bosaya (denosumab-kyqq) and Aukelso (denosumab-kyqq) are biosimilars of Amgen’s Prolia and Xgeva, respectively.

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Bosaya is approved as a 60 mg/mL injection for single-use prefilled syringes. It targets post-menopausal osteoporosis, osteoporosis in men at high risk, glucocorticoid-induced osteoporosis, and bone loss in men undergoing androgen deprivation therapy for prostate cancer or women on adjuvant aromatase inhibitors for breast cancer.

Aukelso is approved as a 120 mg (1.7 mL, 70 mg/mL) single-dose vial. It’s meant for prevention of skeletal-related events in multiple myeloma and metastatic solid tumours, treatment of giant cell tumour of bone (when surgery isn’t feasible), and for hypercalcemia of malignancy not responding to bisphosphonates.

Both products carry a provisional interchangeability designation from the USFDA, meaning they can be substituted for their reference biologics under certain conditions.

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Safety, Efficacy & Regulatory Notes

Clinical trials and analysis show that Bosaya and Aukelso match their reference products in terms of safety, quality, and efficacy.

The reference product Prolia and Bosaya share the same Risk Evaluation and Mitigation Strategy (REMS), which is specifically designed to monitor risks such as severe hypocalcemia, including in patients with advanced chronic kidney disease.

Effects on Healthcare and PatientsLess expensive treatment options: This medication is anticipated to be less expensive than branded biologics and may provide comparable therapeutic benefits, as is the case with the majority of biosimilars. This may reduce costs for patients needing denosumab therapy.

Increased Access: Patients suffering from osteoporosis, bone metastases, or cancer-related bone disorders may access better treatment in the United States and other regions.

Increased competition: The entry of Bosaya and Aukelso may lead to better pricing, improved insurance coverage, and advances in the biologics market.

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FAQs on Osteoporosis and Bone Loss Drug

1. What is osteoporosis?
Osteoporosis is a condition that weakens bones, increasing the risk of fractures.

2. Who is at risk for osteoporosis?
Older people, particularly post-menopausal women, are at higher risk, but men can develop it too.

3. What factors contribute to osteoporosis?
Age, hormonal changes, certain medications, and lifestyle factors such as inactivity and poor diet can contribute to bone loss.

4. What are Bosaya and Aukelso?
They are biosimilars to Amgen’s Prolia and Xgeva, approved for treating various bone-related conditions.

5. How do Bosaya and Aukelso impact healthcare?
They offer less expensive treatment options and may improve access and competition in the biologics market.

Disclaimer: This article, including health and fitness advice, only provides generic information. Don’t treat it as a substitute for qualified medical opinion. Always consult a specialist for a specific health diagnosis.