Biocon Biologics Inpremzia gets backing from EMA expert panel

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 lnpremzia -- insulin human (rDNA), a fast-acting human insulin for injection.

Inpremzia is a pre-mixed ready-to-use insulin for IV infusion for patients in hospital and other acute care settings. lnpremzia 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 commercialized in the EU by a leading global medical products company.

Biocon Biologics has developed and supplied the USFDA 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 license and supply agreement signed between the two companies.

Shreehas Tambe, Deputy CEO, Biocon Biologics said: "The CHMP's decision to recommend lnpremzia, an innovative rh-insulin IV formulation developed by our partner, for approval in the EU, is yet another milestone in our mission to broaden access. 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. This decision further builds on our success with biosimilar Insulin Glargine which is already available in many markets across the EU."