Biocon Biologics' partner receives positive EU CHMP opinion for its Biosimilar Human Insulin

1 Apr 2022 , 10:38 AM

Biocon Limited informed that its subsidiary, Biocon Biologics Limited, received a positive opinion from the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP), recommending the granting of a marketing authorization 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), fast-acting human insulin for injection.

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.

Biocon is currently trading at Rs339.25 up by Rs4.7 or 1.4% from its previous closing of Rs334.55 on the BSE. The scrip opened at Rs336.40 and has touched intraday high and low of Rs342.10 and Rs336.40 respectively.