Biocon Biologics Ltd. (BBL), a subsidiary of Biocon Ltd., 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 Pharmaceuticals LLC (Celerity), 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 has developed the drug substance of Inpremzia — 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. 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 commercialized 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 license and supply agreement signed between the two companies.

Shreehas Tambe, Deputy CEO, Biocon Biologics said:

The CHMP’s decision to recommend Inpremzia, 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.

Dan Robins, Ph.D., president, Celerity, said:

Obtaining positive CHMP opinion for Inpremzia is a significant achievement in our continued efforts to introduce medicines in new presentations that help promote clinician efficiency and advance patient care.

A biosimilar medicinal product, Inpremzia is highly similar to the reference product Actrapid (human insulin), which was authorised in the EU on 7 October 2002. Data show that Inpremzia has comparable quality, safety and efficacy to Actrapid (human insulin).