Biocon Biologics’ biosimilar human insulin gets backing from EMA expert panel
Biocon Biologics, a subsidiary of Biocon on Friday said the European Medicines Agency’s (EMA) expert panel has recommended the granting of a marketing authorisation for Inpremzia, a biosimilar version of Actrapid (human insulin). The EMA’s Committee for Medicinal Products for Human Use (CHMP) opinion will be considered by the European Commission. “The European Commission decision on the approval is expected later this year,” Biocon Biologics said. Once approved by EMA, the company said it commercialise Inpremzia in the EU by a leading global medical products company. Biocon Biologics has developed the drug substance of Inpremzia — insulin human (rDNA), a fast-acting human insulin for injection, while its partner Celerity Pharmaceuticals a ready-to-use insulin formulation for intravenous (IV) infusion. Biocon 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. Inpremzia is formulated as pre-mixed ready-to-use insulin for IV infusion in hospitalised patients using recombinant human insulin 1 U/mL (100 U/100 mL) in 0.9% sodium chloride. 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,” the drugmaker 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,” said Shreehas Tambe, deputy CEO of Biocon Biologics. “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,” Tambe added. “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,” said Dan Robins, president, Celerity 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). Biocon Biologics’ rh-insulin product has been commercialized in almost 40 countries across the world. Shares of Biocon rose 2.21% and were trading at Rs 341.95 on BSE on Friday at 9.40 am, the benchmark Sensex gained 0.03% at 58,584.49 points.