Biocon Biologics gets European Medicines Agency's backing for Inpremzia

Biocon Biologics, an arm of Biocon Ltd, on Friday said a committee of the European Medicines Agency has recommended the granting of marketing authorization for its biosimilar, Inpremzia, a pre-mixed ready-to-use insulin formulation for intravenous infusion.

Impreza has been developed by Celerity Pharmaceuticals LLC using Biocon Biologics' biosimilar insulin drug substance, Biocon Ltd said in a regulatory filing.

''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),'' the company said.

CHMP's decision to recommend Inpremzia for approval in the EU is yet another milestone in the company's mission to broaden access, Biocon Biologics Deputy CEO Shreehas Tambe said.

''The positive opinion by CHMP underscores our scientific and technical capabilities in developing and manufacturing a high-quality insulin drug substance that can be formulated to offer multiple drug delivery options to people living with diabetes globally,'' Tambe added.

The company said Inpremzia is highly similar to the reference product Actrapid (human insulin) which was authorized in the EU on October 7, 2002.

Impreza is pre-mixed ready-to-use insulin for intravenous infusion for patients in hospitals and other acute care settings. It helps in lowering blood glucose by facilitating the uptake of glucose into muscle and fat cells and by simultaneously inhibiting glucose output from the liver.

Biocon Biologics said the CHMP positive opinion will be considered by the European Commission and an approval decision is expected later this year.

Once approved, the company said Inpremzia will be commercialized in the EU by a leading global medical products company without disclosing further details.