The company will be eligible to have exclusivity for 12 months before the FDA can approve another biosimilar interchangeable to Lantus. Commercial preparations for launch are underway. Over the next few months, Viatris will transition the current product to the 351(k) interchangeable product.

Semglee is indicated to control high blood sugar in adults with Type 2 diabetes and adults and pediatric patients with Type 1 diabetes. It is not recommended for the treatment of diabetic ketoacidosis. Semglee has an identical amino acid sequence to Lantus and is approved for the same indications.

Biocon Biologics, executive chairperson, Kiran Mazumdar-Shaw said, “We are extremely proud to be the first to obtain approval of an interchangeable Biosimilar product in the U.S. It is a milestone achievement for both Biocon Biologics and our partner Viatris. This will allow pharmacy level substitution and thereby provide convenient and affordable access to Semglee, a quality Biosimilar Insulin Glargine.”

Biocon Biologics, MD Arun Chandavarkar said, “This interchangeability approval for Semglee by the U.S. FDA, another first to our credit, is a testament to our scientific excellence and robust quality comparability data. This allows substitution at the pharmacy counter, thus expanding patient access and sets the stage for future approvals for our other insulin products.”

Biocon Biologics, a subsidiary of Biocon, is a fully integrated global biosimilars organization. It is leveraging cutting-edge science, innovative tech platforms and advanced research & development capabilities to lower treatment costs while improving healthcare outcomes.

Biocon is an innovation-led global biopharmaceuticals company committed to enhance affordable access to complex therapies for chronic conditions like diabetes, cancer and autoimmune.

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