Biocon Biologics’ partner receives positive EU CHMP opinion for biosimilar human insulin for IV infusion

Biocon Biologics announced today the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion, recommending the granting of a marketing authorisation for Inpremzia, a biosimilar version of Actrapid (human insulin). This is a ready‐to‐use insulin formulation for intravenous (IV) infusion developed by Celerity Pharma, using Biocon Biologics’ biosimilar human insulin drug substance, Biocon said in a statement.

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 has developed the drug substance of Inpremzia ‐‐ insulin human (rDNA), a fast‐acting human insulin for injection, it further said.

Further, according to the statement, Inpremzia is a pre‐mixed ready‐to‐use insulin for IV infusion for patients in hospital and other acute care settings. Inpremzia would help lower blood glucose by facilitating uptake of glucose into muscle and fat cells and by simultaneously inhibiting glucose output from the liver. This presentation would offer convenience in administration and better patient experience. Once approved, Inpremzia will be commercialised in the EU by a leading global medical products company.

Biocon Biologics has developed and supplied the US FDA-approved biosimilar human insulin drug substance for Inpremzia and also has supported Celerity by providing relevant data, regulatory and technical expertise throughout the development of the final drug product under a licence and supply agreement signed between the two companies, the statement mentioned.