Biocon, Mylan get U.S. FDA approval for insulin glargine injection
It will increase access and affordability of insulin for millions of Americans with diabetes.
Semglee, a drug for diabetics, co-developed by Mylan and Biocon Biologics, has secured U.S. FDA approval
Biocon Ltd. and Mylan N.V. on June 12 announced that the U.S. Food and Drug Administration (FDA) has approved the New Drug Application (NDA) for Semglee (insulin glargine injection), in vial and pre-filled pen presentations, to control high blood sugar in adults with type 2 diabetes, and adult and pediatric patients with type 1 diabetes.
Semglee has an identical amino acid sequence to Sanofi’s Lantus and is approved for the same indications. Semglee was approved as a drug product and is now deemed a biologic.
Kiran Mazumdar Shaw, chairperson, Biocon, said: “The approval of our insulin glargine by the U.S. FDA marks the culmination of a long journey. As an organisation committed to making insulin-based therapy increasingly accessible for people with diabetes globally, I am glad this approval will enable us to serve the needs of patients in the U.S. The approval is also an endorsement of our science, scale and expertise to develop high quality, more affordable insulins and shift the access paradigm in favour of patients, taking us closer to realising our aspiration of reaching ‘one in five’ insulin-dependent people with diabetes worldwide.”
Dr. Christiane Hamacher, CEO and managing director, Biocon Biologics, said, “Our combined scientific expertise and global scale manufacturing capability complemented by a comprehensive product presentation across vials and pens will enable us to expand patient access to our insulin glargine through our partner Mylan. Biocon Biologics is committed to impact 5 million patients globally by FY 22.”
She added: “The global clinical studies have demonstrated no difference in safety, efficacy and immunogenicity of Semglee in comparison to the reference product, Lantus, in type 1 and type 2 diabetes. Our goal is to enable access to patients in need of insulins, and we are working towards creating a patient ecosystem that helps in lowering co-morbidities and achieving overall cost savings for the healthcare systems.”
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