Biocon Biologics’ Kirsty (Biosimilar, NovoLog) Secures the US FDA’s Approval
Shots:
- The US FDA has approved Kirsty (100 units/mL), an interchangeable biosimilar of NovoLog (Insulin Aspart) to improve glycemic control in adults & pediatric pts with diabetes mellitus
- Approval was based on comprehensive analytical, non-clinical, & clinical data, which showed similar efficacy, safety, purity & potency of Kirsty vs NovoLog
- Kirsty is a rapid-acting human insulin analog that will be available as a prefilled pen for SC use as well as a vial for both SC & IV use
Ref: Biocon| Image: Biocon| Press Release
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