Biocon Biologics, a subsidiary of Biocon Limited, has achieved a significant milestone in the Canadian healthcare market. The company's biosimilar drug Yesafili (aflibercept) has been added to Ontario's Public Drug Formulary, marking an important step in expanding access to treatment for patients with retinal diseases in Canada.

Expanded Access for Retinal Disease Patients

The inclusion of Yesafili in Ontario's public drug program is set to have a substantial impact on patient care:

• Funded Access: Patients with retinal diseases in Ontario will now have funded access to Yesafili through the public healthcare system.
• Broader Reach: This development is expected to make the treatment more accessible to a larger patient population in Canada's most populous province.
• Cost-Effective Treatment: As a biosimilar, Yesafili offers a more affordable alternative to the original biologic drug, potentially reducing the financial burden on both patients and the healthcare system.

About Yesafili

Yesafili is Biocon Biologics' biosimilar version of aflibercept, a medication used to treat various retinal conditions:

• Indications: Commonly used for age-related macular degeneration (AMD), diabetic macular edema (DME), and other retinal disorders.
• Mechanism: Works by inhibiting vascular endothelial growth factor (VEGF), which is responsible for the abnormal growth of blood vessels in the eye.

Implications for Biocon Biologics

This regulatory achievement represents a significant opportunity for Biocon Biologics:

• Market Expansion: Inclusion in Ontario's formulary opens up a substantial market for Yesafili in Canada.
• Competitive Position: Strengthens Biocon Biologics' position in the global biosimilars market, particularly in North America.
• Revenue Potential: The funded access is likely to drive uptake of Yesafili, potentially boosting the company's revenue from this product.

The addition of Yesafili to Ontario's Public Drug Formulary underscores Biocon Biologics' commitment to expanding access to affordable, high-quality biosimilars. This development not only benefits patients in Canada but also reinforces the company's growing presence in the global pharmaceutical market.

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.