On July 15, 2025, Biocon Biologics, a fully integrated global biosimilars company and a subsidiary of Biocon Ltd., announced that the FDA has approved KIRSTY (insulin aspart-xjhz injection), 100 units/mL, as the first and only interchangeable biosimilar to Novo Nordisk’s NOVOLOG (insulin aspart injection) in the United States. KIRSTY is a rapid-acting human insulin analog indicated to improve glycemic control in adults and pediatric patients with diabetes mellitus.
KIRSTY will be available in the U.S. market as a single-patient-use prefilled pen for subcutaneous administration and a multiple-dose vial for both subcutaneous and intravenous use.
This FDA approval marks an important expansion of Biocon Biologics’s biosimilar insulin portfolio in the U.S., which already includes SEMGLEE (insulin glargine-yfgn), the first FDA-approved interchangeable biosimilar insulin. KIRSTY has previously been approved and marketed in Europe and Canada since 2022.
In related news, on July 3, 2025, Biocon Biologics announced that the European Commission (“EC”) granted two denosumab biosimilars, VEVZUO and EVFRAXY, marketing authorization in the European Union. VEVZUO and EVFRAXY reference Amgen’s XGEVA and PROLIA, respectively.
The EC authorized Biocon Biologics’s VEVZUO for the prevention of bone complications in adults with advanced forms of bone cancers, and the treatment of adults with bone giant cell tumors. EVFRAXY is authorized for the treatment of osteoporosis and bone loss.
VEVZUO and EVFRAXY join a growing list of denosumab biosimilars with EC approval, including Celltrion’s OSENVELT and STOBOCLO; Sandoz’s WYOST and JUBBONTI; Samsung Bioepis’s OBODENCE and XBRYX; Gedeon Richter’s JUNOD and YAXWER; mAbxience’s IZAMBY and DENBRAYCE.
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