US FDA approves Biocon’s insulin glargine injection Semglee
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, announced Biocon and Mylan on June 12.

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.

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. ”

Biocon 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."

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