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Biocon Biologics Receives FDA Approval for Bosaya™ and Aukelso™

Biocon Biologics Ltd. (BBL), a leading company in the biosimilars sector, has proudly announced that the U.S. Food and Drug Administration (FDA) has granted approval for two of its key biosimilars: Bosaya™ and Aukelso™. This significant milestone marks a step forward in making effective treatment options more accessible for patients suffering from osteoporosis and certain types of cancer.

FDA Approval Details

The FDA has approved Bosaya™ (denosumab-kyqq), designed for subcutaneous administration through a prefilled syringe, and Aukelso™ (denosumab-kyqq), which is provided in a single-dose vial. Both products are biosimilars to Prolia® and Xgeva®, respectively, and the FDA has also granted provisional interchangeability designations for these treatments.

Shreehas Tambe, the CEO and Managing Director of Biocon Biologics, underscored the approval as a pivotal moment in their continuous mission to extend access to important biologic therapies. He stated, “With Bosaya™, we welcome a more affordable treatment option for patients with osteoporosis, while Aukelso™ enhances our oncology care offerings.” This development not only reflects the company’s capacity for scientific and regulatory achievements but also its unwavering commitment to delivering high-quality biosimilars that bolster sustainable healthcare systems.

Indications and Market Impact

Bosaya™

Bosaya™ is indicated for a variety of conditions, including:

• - Treatment of postmenopausal women with osteoporosis who are at a high risk for fractures.
• - Increasing bone mass in men with high-risk osteoporosis.
• - Addressing glucocorticoid-induced osteoporosis in both genders.
• - Enhancing bone mass in men undergoing androgen deprivation therapy for nonmetastatic prostate cancer.
• - Supporting women at risk for fractures receiving aromatase inhibitor therapy for breast cancer.

Aukelso™

On the other hand, Aukelso™ has been cleared for:

• - Prevention of skeletal-related events in patients with bone metastases or multiple myeloma.
• - Treatment of adolescents and adults with unresectable giant cell tumor of bone.
• - Management of hypercalcemia of malignancy when resistant to bisphosphonate therapy.

These approvals are particularly timely, as the U.S. market for denosumab products had reported sales close to $5 billion by the end of 2024, with Prolia® and Xgeva® accounting for $3.3 billion and $1.6 billion, respectively.

The Importance of Accessibility in Osteoporosis Treatment

Osteoporosis remains a critical public health issue in the U.S., affecting about 10 million adults over 50 and placing an additional 44 million at risk due to low bone density. Remarkably, one in two women and one in four men over the age of 50 could suffer a fracture related to this condition in their lifetimes. The launch of Bosaya™ is expected to provide a more affordable option, critically needed given the rising healthcare costs and the increasing prevalence of osteoporosis.

Similarly, bone metastases significantly affect cancer patients, with roughly 330,000 individuals being impacted annually in the U.S. Therefore, Aukelso™ is poised to address a substantial healthcare need that can dramatically affect a patient's quality of life.

How the Biosimilars Work

Both biosimilars utilize denosumab, a monoclonal antibody that targets the Receptor Activator of Nuclear Factor Kappa-B Ligand (RANKL), a crucial player in bone resorption. By inhibiting RANKL, denosumab helps increase bone strength and mass, which is especially beneficial in treating osteoporosis and certain cancer-related complications.

Safety and Monitoring

Both products share safety profiles similar to their reference drugs, with an emphasis on monitoring for potential adverse reactions, such as severe hypocalcemia, particularly in patients with advanced kidney disease. A Risk Evaluation and Mitigation Strategy (REMS) has been established for Bosaya™ to ensure that both healthcare providers and patients are adequately informed of potential risks assenting to the therapy.

In conclusion, the FDA's approval of Bosaya™ and Aukelso™ represents not just a win for Biocon Biologics but a crucial advance in improving patient access to necessary treatments in the realm of oncology and bone health. This move not only aims to benefit patients financially but also represents an integral part of Biocon's broader strategy to enhance global healthcare accessibility.

For more information about Biocon Biologics and their commitment to transforming healthcare through innovative biosimilars, visit Biocon Biologics.