Business
Viatris Inc. and Biocon Biologics Receive Historic Approval for First Interchangeable Biosimilar Semglee® (insulin glargine-yfgn injection) for the Treatment of Diabetes
Interchangeable Designation Allows Substitution at the Pharmacy Counter for Lantus® Across the U.S. to Help Increase Access to Medicines for People Living
About this update from Viatris Inc.
[{"type":"text","content":"Interchangeable Designation Allows Substitution at the Pharmacy Counter for Lantus® Across the U.S. to Help Increase Access to Medicines for People Living with Diabetes\n Company is Eligible for 12 Months of First Interchangeable Exclusivity from the Date of Commercial Launch\n\n\nPITTSBURGH and BENGALURU, India, July 28, 2021 /PRNewswire/ -- Viatris Inc. (NASDAQ: VTRS) and Biocon Biologics Ltd. (a subsidiary of Biocon Ltd.) today announced that the U.S. Food and Drug Administration (FDA) has approved Semglee® (insulin glargine-yfgn injection) as the first interchangeable biosimilar product under the 351(k) regulatory pathway. \nViatris CEO Michael Goettler commented: \"We are extremely proud to achieve the industry's first approval of an interchangeable biosimilar product in the U.S., which will help broaden access to this important diabetes medicine for patients, physicians, payers and providers. This is yet another important milestone for our company that not only continues to underscore the strength of our internal scientific capabilities, but also supports our belief in the promising future of our company as we continue to work to identify innovative ways to increase access to complex treatments for patients.\"\nViatris President Rajiv Malik added: \"We are very pleased to have once again worked with the FDA to achieve the very historic approval of the first interchangeable biosimilar in the U.S. and are grateful to our partner, Biocon Biologics, for their collaboration in achieving this milestone. Our continued ability to break down barriers to access, bring forth first-to-market products and blaze new trails is a testament to the strength of our scientific, regulatory, operations and legal expertise as well as our focus on patients.\" \nThe interchangeable Semglee product, which will allow substitution of Semglee for the reference product, Lantus®, at the pharmacy counter, will be introduced before the end of the year. The company is 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. \nSemglee is indicated to control high blood sugar in adults with Type 2 diabetes and adults and pediatric patients with ...