Biocon Biologics Gets U.S. FDA Nod for Kirsty™, First Interchangeable Insulin Aspart Biosimilar

Bengaluru, July 16, 2025 – Biocon Limited (BSE: 532523, NSE: BIOCON) announced a significant regulatory milestone as its subsidiary, Biocon Biologics Ltd (BBL), received U.S. FDA approval for Kirsty™, the first and only interchangeable biosimilar to NovoLog® (Insulin Aspart) in the United States.

FDA Approval Expands Biocon’s Diabetes Portfolio

With this approval, Biocon Biologics becomes the only company to offer an interchangeable rapid-acting Insulin Aspart biosimilar in the U.S. market. Kirsty™ (Insulin Aspart-xjhz) 100 units/mL is indicated for glycemic control in adults and children with diabetes mellitus.

Kirsty™ will be available in two convenient formats:

• a prefilled pen designed for single-patient use via subcutaneous injection,
• a multiple-dose vial that can be used for both subcutaneous and intravenous administration.

This approval builds on the company’s earlier success with Semglee® (Insulin Glargine-yfgn), the first interchangeable insulin biosimilar approved in the U.S.

“The FDA approval of Kirsty™, the first and only interchangeable biosimilar rapid-acting Insulin Aspart in the U.S., is a significant step forward in our efforts to make insulin more accessible and affordable,” said Shreehas Tambe, CEO & MD, Biocon Biologics Ltd. “With Kirsty™, we are expanding treatment choices for people living with diabetes and advancing our ambition to be a global leader in addressing unmet needs in diabetes care.”

U.S. Diabetes Market: A Significant Opportunity

An estimated 38.4 million people in the U.S. about 11.6% of the population are living with diabetes, and nearly 97.6 million more are considered prediabetic. In 2024 alone, Insulin Aspart generated $1.9 billion in U.S. sales, as per IQVIA data, highlighting a strong market potential for Kirsty™.

Product Profile: Kirsty™ at a Glance

FDA Interchangeability Criteria Met:

Kirsty™ was approved based on robust analytical, clinical, and safety data demonstrating:

• High similarity to NovoLog®
• No clinically meaningful differences
• Proven efficacy, safety, and immunogenicity profiles

Safety Highlights and Contraindications

Kirsty™ is contraindicated in:

• Episodes of hypoglycemia
• Patients with hypersensitivity to insulin aspart or its excipients

Key warnings and precautions include:

• Hypoglycemia and hyperglycemia risk with regimen changes
• Risk of hypokalemia and hypersensitivity reactions
• Instructions to avoid pen-sharing and monitor insulin mix-up errors

Biocon Biologics: Global Biosimilars Leader

Biocon Biologics has now commercialized nine biosimilars and supplies over 9.2 billion doses of insulin globally. The company operates in over 120 countries and serves more than 5.8 million patients annually.

Its biosimilars pipeline includes 20 assets across therapeutic areas like diabetology, oncology, immunology, and ophthalmology. BBL holds several “firsts” in the industry, including U.S. approvals for:

• Ogivri® (biosimilar Trastuzumab)
• Fulphila™ (biosimilar Pegfilgrastim)
• Semglee® (biosimilar Insulin Glargine)

Biocon Stock Performance

Biocon shares gained 1.09% on July 16, 2025, at 9:43 AM IST, trading at ₹394, up ₹4.25. In the National Stock Exchange, Biocon shares have gained 11% over the last year, 7% year-to-date, and 10% in the previous month.

About Biocon Limited

Biocon Limited, listed since 2004, is a global innovation-led biopharma company focused on affordable access to complex therapies in diabetes, cancer, and autoimmune diseases. It operates across biologics, biosimilars, APIs, and novel immunotherapy pipelines in both emerging and developed markets, including the U.S. and Europe.

REF: https://nsearchives.nseindia.com/corporate/Bioconlimited_16072025000015_CoverLetterpressrelease.pdf

Disclaimer:  At HDFC SKY, we take utmost care and due diligence in curating and presenting news and market-related content. However, inadvertent errors or omissions may occasionally occur.

If you have any concerns, questions, or wish to point out any discrepancies in our content, please feel free to write to us at content@hdfcsec.com.

Please note that the information shared is intended solely for informational purposes and does not make any investment recommendations