Biocon Biologics gets USFDA nod for rapid-acting insulin

Biocon Biologics

Biocon Biologics has got the US Food and Drug Administration’s approval for Kirsty, a diabetes medication, paving the way for its launch in the US, a the Biocon subsidiary announced on July 16.

Kirsty will be the first and only interchangeable biosimilar to NovoLog (Insulin Aspart) in the US, positioning it as a compelling yet affordable alternative.

"It's a significant step forward in our efforts to make insulin more accessible and affordable," said Shreehas Tambe, CEO & Managing Director, Biocon Biologics. It builds on “the foundation we laid with Semgle, reinforcing our commitment to scientific excellence and patient-centric innovation", he said.

A rapid-acting human insulin analog, Kirsty is indicated to improve glycaemic control in both adult and paediatric patients with diabetes. It will be available in both a single-patient-use prefilled pen and a multiple-dose vial, catering to various needs.

The FDA's green light for Kirsty significantly expands Biocon Biologics' biosimilar insulin portfolio. It joins Semglee (Insulin Glargine-yfgn Injection), which was the first approved interchangeable biosimilar, solidifying the company's position in the diabetes treatment landscape.

Kirsty has been available in Europe and Canada since 2022, indicating a proven track record outside the demanding US market.

The company said the approval is a testament to its robust development capabilities, with the decision based on a comprehensive package of analytical, nonclinical, and clinical data.

This data confirmed Kirsty is "highly similar to Novolog" with "no clinically meaningful differences" in terms of safety, efficacy, purity, and potency, it said.

The US diabetes market presents a substantial opportunity for Biocon Biologics. With 38.4 million people living with diabetes, representing nearly 11.6 percent of the American population, and sales of Insulin Aspart alone reaching approximately $1.9 billion in 2024, Kirsty is poised to address a significant unmet need for affordable treatment options.

At 11.30 am, the Biocon stock was trading at Rs 396 on BSE, rising 1.49 percent from the previous close even as the benchmark Sensex was down 0.18 percent at 82,421.26.

Biocon Biologics is ranked among the top three firms globally for rh-Insulin and Insulin Glargine, having provided over 9.2 billion insulin doses worldwide.

The company boasts has a history of  many "firsts," including the first approvals for biosimilar Trastuzumab (Ogivri), Fulphila (biosimilar of Pegfilgrastim), and Semglee (biosimilar of Insulin Glargine) in the US.

Biosimilar drugs are a type of biological medicine highly similar to already approved products but are not exact copies. They are is almost no difference in terms of safety, effectiveness, and quality compared to the reference product. They offer a cheaper option at the same strength.