Biocon Biologics Ltd. (BBL), a subsidiary of Biocon Ltd., has announced a significant milestone in its expansion into the U.S. pharmaceutical market. The company has secured approval dates for its denosumab biosimilars, Bosaya™ and Aukelso™, marking a crucial step in its strategy to broaden access to advanced biologic medicines.

Settlement Agreement Clears Path for Commercialization

BBL has reached a settlement and license agreement with Amgen Inc., resolving pending patent litigation at the United States District Court for the District of New Jersey. This agreement paves the way for Biocon Biologics to launch Bosaya™ and Aukelso™ in the U.S. market from October 1, 2025.

About the Biosimilars

Bosaya™ and Aukelso™ are biosimilar versions of Amgen's Prolia® and Xgeva®, respectively. These products are used in the treatment of osteoporosis and cancer-related bone conditions:

• Bosaya™: A 60 mg/mL injection in a single-dose prefilled syringe (PFS)
• Aukelso™: A 120 mg/1.7 mL (70 mg/mL) injection for subcutaneous use in a single-dose vial

FDA Approval and Interchangeability

The U.S. Food and Drug Administration (FDA) approved both Bosaya™ and Aukelso™ in September 2025. Notably, the FDA also granted provisional interchangeability designation for both biosimilars, potentially enhancing their market position.

Treatment Applications

Bosaya™ Indications

• Treatment of postmenopausal women with osteoporosis at high risk for fracture
• Increasing bone mass in men with osteoporosis at high risk for fracture
• Treatment of glucocorticoid-induced osteoporosis in men and women at high risk for fracture
• Increasing bone mass in men receiving androgen deprivation therapy for nonmetastatic prostate cancer
• Increasing bone mass in women receiving adjuvant aromatase inhibitor therapy for breast cancer

Aukelso™ Indications

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

Market Impact and Company Strategy

Shreehas Tambe, CEO & Managing Director of Biocon Biologics, emphasized the significance of this development: "This settlement paves the way for Biocon Biologics to bring our high-quality denosumab biosimilars, Aukelso™ and Bosaya™, to patients and healthcare providers in the United States. These therapies will not only strengthen our oncology portfolio but also mark our entry into the bone health space—an important step as we continue to broaden access to life-changing biologics for patients across therapeutic areas."

Market Potential

The introduction of these biosimilars addresses significant health concerns in the U.S.:

Conclusion

Biocon Biologics' successful entry into the U.S. market with Bosaya™ and Aukelso™ represents a significant step in the company's global expansion strategy. By providing more affordable alternatives to established treatments for osteoporosis and cancer-related bone conditions, Biocon Biologics aims to improve patient access to critical therapies while strengthening its position in the competitive biosimilars market.

Biocon Limited , a leading biopharmaceutical company, has received a Show Cause Notice from the Office of the Deputy Commissioner of Commercial Taxes in Karnataka, proposing a total demand of Rs. 2.02 crore for the Financial Year 2021-22. The notice, dated September 24, 2025, outlines several tax-related issues and demands.

Breakdown of the Tax Demand

The proposed demand of Rs. 2,02,34,997 comprises:

Key Issues Highlighted in the Notice

The tax authorities have identified seven specific issues:

1. Credit note related turnover wrongly reduced from taxable turnover
2. Short declaration of outward supplies in monthly returns
3. Credit note on exports
4. Wrong claim of lower tax on merchant export benefits
5. Non-payment of tax on corporate guarantee
6. Delayed payment to suppliers beyond 180 days
7. Input tax credit mismatch between monthly returns (GSTR-3B) and input tax credit reported by suppliers (GSTR-2B)

Company's Response

Biocon has stated that there is no material impact on the company's financials, operations, or other activities due to this notice. The company is in the process of taking appropriate actions to address the Show Cause Notice.

Disclosure and Compliance

In compliance with Regulation 30 of SEBI (Listing Obligations and Disclosure Requirements) Regulations, 2015, Biocon has promptly disclosed this information to the stock exchanges. Mukesh Kamath, Interim Chief Financial Officer of Biocon, has confirmed that the information provided is true, correct, and complete to the best of his knowledge and belief.

Implications and Next Steps

While the tax demand is significant, Biocon maintains that the impact will be limited to the extent of the final liability as may be ascertained, along with any applicable interest and penalties. The company has not provided specific details on its strategy to contest or resolve the issues raised in the notice.

Investors and stakeholders will likely be watching closely to see how Biocon addresses these tax matters and whether there will be any long-term implications for the company's financial reporting or tax practices.