Biocon Limited has submitted its quarterly compliance certificate under Regulation 74(5) of the Securities and Exchange Board of India (Depositories and Participants) Regulations, 2018 for the quarter ended March 31, 2026. The certificate was filed with both BSE Limited and National Stock Exchange of India Limited on April 07, 2026.

Regulatory Compliance Certificate

The certificate confirms that Biocon has furnished details of securities dematerialized and rematerialized during the quarter ended March 31, 2026 to all stock exchanges where the company's shares are listed. This filing is a mandatory requirement under SEBI regulations to ensure transparency in share transfer processes.

Registrar Confirmation

KFin Technologies Limited, serving as Biocon's Registrar and Share Transfer Agent, provided confirmation dated April 04, 2026 regarding compliance with regulatory requirements. The registrar confirmed that during the period from January 1, 2026 to March 31, 2026, all dematerialization processes were handled in accordance with SEBI regulations.

Key Compliance Activities

KFin Technologies confirmed completion of the following regulatory requirements:

• Confirmed demat requests within 15 days of receipt from depository participants
• Verified that securities in certificates were listed on appropriate stock exchanges
• Properly mutilated and cancelled security certificates after verification
• Updated member registers with depository names as registered owners for approved demat requests

Corporate Filing Details

The certificate was signed by Rajesh Umakant Shanoy, Company Secretary and Compliance Officer of Biocon Limited, with membership number ACS 16328. The filing was made to both major Indian stock exchanges where Biocon shares are traded.

This quarterly filing demonstrates Biocon's ongoing commitment to regulatory compliance and transparency in its share transfer and dematerialization processes as required under SEBI guidelines.

Biocon Limited has announced the commercial launch of two denosumab biosimilars in the United States, marking a significant expansion of the company's biosimilars portfolio. The launch of Bosaya™ and Aukelso™ follows FDA approval with interchangeable designation received in September 2025.

Product Launch Details

Both biosimilar products are now available by prescription nationwide through specialty pharmacies and healthcare providers. The interchangeable designation allows substitution at the pharmacy level in accordance with state laws, providing greater accessibility for patients.

Market Opportunity and Patient Impact

The launch addresses substantial unmet medical needs in bone health management. According to the company's announcement, approximately 10 million adults with osteoporosis and over 330,000 patients annually with bone metastasis could potentially benefit from these biosimilar alternatives.

Denosumab products represent a significant market segment, generating approximately $5 billion in US sales in 2024. This substantial market size reflects the growing demand for accessible treatment options in bone health management.

Clinical Applications

Denosumab functions as a human monoclonal antibody that targets and binds to Receptor Activator of Nuclear Factor Kappa-B Ligand (RANKL). By blocking RANKL, the medication reduces bone breakdown, thereby increasing bone mass and strength.

Osteoporosis Treatment

Osteoporosis affects approximately 10 million adults over age 50 in the United States, with another 44 million at risk due to low bone density. The condition significantly impacts patient outcomes, with one in two women and up to one in four men over age 50 experiencing bone fractures due to osteoporosis.

Bone Metastasis Management

Bone metastases represent a common complication of advanced cancer, affecting more than 330,000 patients annually in the United States. These skeletal complications can significantly impair quality of life and increase healthcare burden for cancer patients.

Leadership Perspective

Shreehas Tambe, CEO & Managing Director of Biocon Limited, emphasized the strategic importance of this launch: "The U.S. introduction of Bosaya™ and Aukelso™ marks a strategic expansion of our biosimilars portfolio, building on our established leadership in oncology and immunology. These therapies broaden access to high-quality, affordable treatment options for patients living with serious bone conditions."

Safety Considerations

Both products carry important safety warnings and precautions. Bosaya™ includes a boxed warning regarding severe hypocalcemia risk in patients with advanced kidney disease. Healthcare providers must evaluate patients with chronic kidney disease-mineral bone disorder before initiating treatment.

Company Background

Biocon Limited operates as a global biopharmaceutical company focused on providing affordable, life-changing medicines worldwide. The company has commercialized 12 biosimilar products and 30+ generic formulations globally, with operations spanning more than 120 countries and a workforce of over 9,500 employees.