FDA Approval of Biocon Biologics Kirsty™ – First Interchangeable Rapid-Acting Insulin Aspart
In a breakthrough that reinforces India’s growing leadership in global biosimilars, Biocon Biologics has received U.S. FDA approval for Kirsty™ (Insulin Aspart-xjhz) — the first and only interchangeable rapid-acting insulin aspart biosimilar in the United States.
This approval marks a significant leap forward in diabetes care by expanding patient access to high-quality, affordable insulin therapy. Kirsty™ is now the second interchangeable biosimilar from Biocon Biologics, following the success of Semglee® (insulin glargine), and is poised to address the needs of the 38.4 million Americans living with diabetes.
💉 What is Kirsty™?
Kirsty™ is a rapid-acting human insulin analog used to improve glycemic control in adults and pediatric patients with diabetes mellitus. It will be available in two formulations:
- Single-patient-use prefilled pen (subcutaneous use)
- Multiple-dose vial (subcutaneous & intravenous use)
The approval establishes Kirsty™ as interchangeable with NovoLog®, meaning pharmacists in certain U.S. states may substitute it without prescriber intervention, offering a more cost-effective option for patients — much like generics.
🔬 Why It Matters
Biosimilars are biologic drugs that are highly similar to already approved reference products, with no clinically meaningful differences in safety, potency, or efficacy. Interchangeable biosimilars go a step further, meeting additional FDA criteria that allow automatic substitution at the pharmacy, depending on state laws.
This FDA nod was based on extensive analytical, nonclinical, and clinical data, confirming that Kirsty™ mirrors NovoLog® in safety, purity, potency, and effectiveness.
“The FDA approval of Kirsty™ is a significant step forward in our efforts to make insulin more accessible and affordable,” said Shreehas Tambe, CEO & MD, Biocon Biologics Ltd. “It reinforces our commitment to patient-centric innovation and expands treatment choices for people living with diabetes.”
🌍 Global Reach, Local Impact
Kirsty™ has been marketed in Europe and Canada since 2022, and its U.S. approval cements Biocon Biologics’ place among the top three global insulin producers, having delivered over 9.2 billion doses worldwide. The company’s broad insulin portfolio includes basal, mixed, and rapid-acting insulins.
With a growing biosimilars pipeline across oncology, immunology, and endocrinology, Biocon Biologics already serves 5.8 million patients annually, with eight approved biosimilars in the U.S. and seven in Canada.
📈 The Diabetes Landscape in the U.S.
- 38.4 million people have diabetes in the U.S. (~11.6% of the population)
- 97.6 million Americans are prediabetic
- Sales of insulin aspart were valued at ~$1.9 billion in 2024 (IQVIA)
As diabetes cases surge and affordability becomes a key concern, biosimilars like Kirsty™ could offer life-changing access to essential insulin therapy.
🧠 Understanding Biosimilars & Interchangeables
Here’s what patients and providers need to know:
- Both biosimilars and interchangeable biosimilars are as safe and effective as their reference products.
- Interchangeable biosimilars can be pharmacy-substituted, easing the cost and access burden.
- These medications enhance treatment options, improve health equity, and reduce out-of-pocket costs.
🔍 To explore more about biosimilars, visit:
👉 FDA Biosimilars Portal
👉 FDA’s 9 Things to Know
👉 FDA Purple Book Database
🔗 Final Word
The FDA approval of Kirsty™ isn’t just a regulatory achievement — it’s a milestone for affordable insulin access, a win for global health equity, and a proud moment for Indian innovation on the world stage. As Biocon Biologics continues to reshape biosimilar accessibility, millions of patients stand to benefit from more choices, better affordability, and improved care.
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