Mylan/Biocon insulin injection approved by FDA
Last Update: 2020-06-16
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On June 11, Mylan and Biocon Biologics announced that the U.SFDA has approved a new drug application for Semglee (insulin glargine injection) in the form of small bottles and prefilled pens to control high blood sugar in adults with type 2 diabetes (T2DM) and in adults and children with type 1 diabetes (T1DM)This approval is based on data from comprehensive analysis, preclinical and clinical trials, including in STRIDE studies, approved for listing under the 505(b) (2) NDA pathway and is considered biological products as other insulin products under Section 351(a) of the Biologics Price Competition and Innovation ActThe INSTRIDE trial confirmed Semglee's pharmacometabolic dynamics/pharmacokinetics, efficacy, safety and immunogenicity in patients with type 1 and type 2 diabetes compared with Sanofi LantusINSTRIDE includes two clinical trials, INSTRIDE 1 and in-type 558 T1DM patients in a 52-week non-poor efficacy study, and INSTRIDE 2 is a 24-week non-de-effectiveness study of 560 T2DM patients in the groupIn both studies, patients were randomly treated with Semglee or Lantus once a day, with the main endpoint being a baseline change in glycated hemoglobin after 24 weeksSecondary endpoints include blood glucose endpoints, such as baseline changes in fasting blood sugar and insulin doses, as well as safe endpoints such as systemic reactions, device-related safety issues, and immunogenicitySafety, effectiveness and immunogenicity data for T1DM and T2DM patients showed no difference between Semglee and LantusSemglee is a long-acting human insulin analogue that has the same amino acid sequence as Lantus and is used to improve blood sugar control in adults with type 1 diabetes and children, as well as in adults with type 2 diabetesTreatment for diabetic ketoacidosis is not recommended and should not be used when hypoglycemia or allergies to insulin glargine or its accessories are not recommendedRajiv Malik, President of Mylan, said, "This landmark regulatory approval makes Mylan the first company to be approved to provide patients with bottling and injection pen-to-insulin treatment scans compared to LantusMylan, who has previously been a supplier of oral diabetes drugs to the U.Smarket, has recently approved a service that extends to people with diabetes who need injections, and Semblee has the potential to further reduce the cost burden on patientsIn April 2018, Semglee received approval from the European Commission, and so far the insulin glycol product has been regulatoryly approved in more than 45 countries around the world, but has been delayed by FDA reviewLantus' market share may be squeezed by Semglee after the U.SlistingFor the 12 months ended April 30, 2020, Lantus's total sales of 100 units/ml of small bottles were approximately $1.68 billion, while the total sales of Lantus SoloSTAR injection pens were approximately $4.33 billion Mylan was awarded a favourable judgment in all of Sanofi's patent-retention claims against Semglee While Sanofi may continue to seek appeal against the sentences, Mylan said he was confident that the final verdict would not affect the commercialization plan Source: Mylan and Biocon Announce U.S FDA Approve of Semglee (insulin glargine injection)
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