Biocon Limited , a leading biopharmaceuticals company, has announced the record date for the buyback of its listed Commercial Paper. The company has set September 18, 2025, as the record date for the buyback of Commercial Paper with ISIN INE376G14032, which is scheduled to take place on September 19, 2025.

Key Details of the Buyback

The company formally communicated this information to both the National Stock Exchange of India Limited (NSE) and BSE Limited through a letter dated September 17, 2025. This move demonstrates Biocon's commitment to managing its financial instruments and maintaining transparency with its investors.

Recent FDA Approval for Biosimilars

In a separate development, Biocon Biologics Ltd. (BBL), a subsidiary of Biocon Ltd., has received approval from the U.S. Food and Drug Administration (FDA) for two denosumab biosimilars:

1. Bosaya™ (denosumab-kyqq) 60 mg/mL injection for subcutaneous use in a single dose prefilled syringe (PFS)
2. Aukelso™ (denosumab-kyqq) 120 mg/1.7 mL (70 mg/mL) injection for subcutaneous use in a single-dose vial

These biosimilars are alternatives to Prolia® and Xgeva® respectively. The FDA has also granted provisional interchangeability designation for both Bosaya™ and Aukelso™.

Market Impact and Applications

The approval of these biosimilars is significant for Biocon Biologics' market position:

• Bosaya™ is approved for treating various forms of osteoporosis and increasing bone mass in specific patient groups.
• Aukelso™ is approved for preventing skeletal-related events in patients with multiple myeloma and bone metastases from solid tumors, among other applications.

According to IQVIA National Sales Perspectives Data, denosumab had nearly $5.00 billion in U.S. sales for the period ended December 2024, with Prolia achieving $3.30 billion and Xgeva generating $1.60 billion.

Company's Perspective

Shreehas Tambe, CEO & Managing Director of Biocon Biologics, stated, "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."

These developments underscore Biocon's ongoing efforts to strengthen its position in the global biopharmaceuticals market, focusing on both financial management and product innovation.

Biocon Biologics Ltd. (BBL), a subsidiary of Biocon Ltd., has achieved a significant milestone in its mission to expand access to critical biologic therapies. The U.S. Food and Drug Administration (FDA) has granted approval for two of the company's biosimilar products, Bosaya™ and Aukelso™, both denosumab biosimilars.

FDA Approval Details

Bosaya™ (denosumab-kyqq), a biosimilar of Prolia®, is a 60 mg/mL injection for subcutaneous use in a single-dose prefilled syringe. Aukelso™ (denosumab-kyqq), a biosimilar of Xgeva®, is a 120 mg/1.7 mL (70 mg/mL) injection for subcutaneous use in a single-dose vial. Both products have received provisional interchangeability designation from the FDA.

Therapeutic Applications

Bosaya™

Bosaya™ is approved for treating osteoporosis in various patient populations, including:

• Postmenopausal women at high risk of fracture
• Men with osteoporosis at high risk of fracture
• Patients with glucocorticoid-induced osteoporosis
• Men receiving androgen deprivation therapy for nonmetastatic prostate cancer
• Women receiving adjuvant aromatase inhibitor therapy for breast cancer

Aukelso™

Aukelso™ is indicated for:

• Preventing skeletal-related events in patients with multiple myeloma and bone metastases from solid tumors
• Treating adults and skeletally mature adolescents with giant cell tumor of bone
• Managing hypercalcemia of malignancy refractory to bisphosphonate therapy

Market Impact

The approval of these biosimilars could have a significant impact on the U.S. healthcare market. According to IQVIA data, denosumab generated nearly $5.00 billion in U.S. sales, with Prolia® accounting for $3.30 billion and Xgeva® for $1.60 billion.

Company Perspective

Shreehas Tambe, CEO & Managing Director of Biocon Biologics, expressed pride in offering more affordable treatment options for patients with osteoporosis and expanding the company's oncology care portfolio. He stated, "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."

Clinical Data and Safety Information

Both biosimilars demonstrated comparable quality, safety, and efficacy to their reference products in clinical trials. Bosaya™ is approved with the same Risk Evaluation and Mitigation Strategy (REMS) plan as Prolia® to inform healthcare providers and patients about the risks of severe hypocalcemia in patients with advanced chronic kidney disease.

Epidemiology and Market Need

Osteoporosis affects approximately 10 million adults over age 50 in the U.S., with another 44 million at risk due to low bone density. The approval of Bosaya™ could potentially increase access to treatment for this significant patient population.

Bone metastases, which Aukelso™ is approved to treat, affect more than 330,000 patients annually in the United States, highlighting the importance of accessible treatment options in oncology care.

The approval of Bosaya™ and Aukelso™ marks another step forward in Biocon Biologics' mission to expand access to critical biologic therapies and improve patient outcomes through high-quality, affordable biosimilars.