Biocon Biologics’ Partner Receives Positive EU CHMP Opinion for Biosimilar Human Insulin for IV Infusion

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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. Biocon Biologics Ltd., a subsidiary of Biocon Ltd., announced today that the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion, recommending the granting of marketing authorization (human insulin). Celerity Pharmaceuticals LLC (Celerity) created this ready-to-use insulin formulation for intravenous (IV) infusion using Biocon Biologics’ biosimilar human insulin medicinal ingredient.

Inpremzia is a human insulin (rDNA origin) 1 U/mL (100 U/100 mL) in 0.9 percent sodium chloride IV infusion in a flexible plastic container. Inpremzia insulin human (rDNA), fast-acting human insulin for injection, was created by Biocon Biologics.

Inpremzia is ready-to-use insulin that has been pre-mixed for IV infusion in hospitals and other acute care settings. Inpremzia lowers blood glucose levels by boosting glucose uptake into muscle and fat cells while also limiting glucose production from the liver. This presentation would make administration easier and provide a better patient experience. Inpremzia will be launched in the EU by a large global medical products firm after it has been approved.

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.

“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,”

Shreehas Tambe, Deputy CEO, Biocon Biologics 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,”

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

Inpremzia is a biosimilar medical product that is very similar to Actrapid (human insulin), which was approved in the EU on October 7, 2002. Inpremzia has equal quality, safety, and efficacy to Actrapid, according to data (human insulin).

The European Commission will take the CHMP’s good judgment into account. The European Commission is anticipated to make a judgment on the approval later this year.

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