## **Biocon Biologics Secures US FDA Nod for Kirsty™ — A Gamechanger for Diabetes Treatment**

**Bengaluru / Bridgewater, July 15, 2025:** Biocon Biologics, the biosimilars arm of Biocon Limited, has announced a significant milestone with the **US FDA approval of Kirsty™ (Insulin Aspart-xjhz)**. Kirsty™ becomes the **first and only interchangeable biosimilar rapid-acting insulin aspart** available in the United States, expanding Biocon Biologics’ global diabetes care portfolio. Kirsty™, a rapid-acting human insulin analog, is approved for improving glycemic control in both adult and pediatric diabetic patients. It will be offered as both a **prefilled pen and a multi-dose vial**. Already available in **Europe and Canada since 2022**, this approval strengthens Biocon’s competitive position in the high-growth US biosimilar insulin market. Biocon Biologics CEO & MD **Shreehas Tambe** stated, “Kirsty’s approval further advances our ambition to democratize access to high-quality, affordable insulin therapies worldwide, reinforcing our leadership in diabetes care solutions.” The US insulin aspart market was valued at **\$1.9 billion in 2024**, underlining the potential commercial impact of this approval. With this milestone, Biocon Biologics builds on the success of its earlier interchangeable insulin biosimilar, **Semglee®**. ### **About Biocon Biologics:** With a presence in over **120 countries**, Biocon Biologics delivers affordable biosimilar solutions to more than **5.8 million patients annually**, offering one of the industry’s broadest portfolios spanning insulin, oncology, and immunology therapies.