CHMP positive opinion for biosimilar human insulin for IV infusion

The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion, recommending the granting of a marketing authorization for Inpremzia, a biosimilar version of Actrapid (human insulin), originated by Novo Nordisk (NOV: N).

This is a ready-to-use insulin formulation for intravenous (IV) infusion developed by Celerity Pharmaceuticals, using Biocon Biologics’ biosimilar human insulin drug substance.

Inpremzia is formulated as an IV infusion in a flexible plastic container, using human insulin (rDNA origin) 1 U/mL (100 U/100 mL) in 0.9% sodium chloride. Biocon Biologics, a subsidiary of India’s Biocon Ltd (BSE: 53223), has developed the drug substance of Inpremzia - insulin human (rDNA), a fast-acting human insulin for injection.