FDA Approves First Interchangeable Biosimilar Insulin
The approval allows for substitution at the pharmacy counter for Lantus, its reference product.
The FDA has approved the first biosimilar insulin to improve glycemic control in adults and pediatric patients with type 1 diabetes and in adults with type 2 diabetes.
Developed by Mylan Pharmaceuticals, now Viatris, in partnership with Biocon Biologics, Semglee (insulin glargine-yfgn) is interchangeable with its reference product, Sanofi’s Lantus (insulin glargine), a long-acting insulin analog. Semglee is the first interchangeable biosimilar product approved in the United States for the treatment of diabetes.
Semglee, offered in 10 mL vials and 3 mL prefilled pens, is administered subcutaneously once daily. It is not recommended for treating diabetic ketoacidosis. In a statement, Viatris officials said commercial preparations for launch are under way.
FDA officials noted that biosimilars typically have launched with initial list prices 15% to 35% lower than comparative list prices of the reference products.
Viatris and Biocon Biologic's insulin glargine has received regulatory approval in more than 60 countries around the world and was the third product approved by the FDA through the Viatris-Biocon Biologics collaboration. The company is eligible to have exclusivity for 12 months before the FDA can approve another biosimilar interchangeable to Lantus.
Viatris was formed in November 2020 after the merger of Mylan and Pfizer’s Upjohn business and has U.S. headquarters in Pittsburgh, Pa.
In this episode of the "Meet the Board" podcast series, Briana Contreras, Managed Healthcare Executive editor, speaks with Ateev Mehrotra, a member of the MHE editorial advisory board and a professor of healthcare policy and medicine at Harvard Medical School. Mehtrotra is also a hospitalist at the Beth Israel Deaconess Medical Center in Boston. In the discussion, Contreras gets to know Mehrotra more on a personal level and picks his brain on some of his research interests including telehealth, alternative payment models and price transparency.
Listen
Diabetes Management & Telehealth with Leslie Kolb
June 11th 2020Association of Diabetes Care and Education Specialists, chief science and practice officer, Leslie Kolb chats with MHE Associate Editor Briana Contreras in MHE's newest podcast Tuning into the C-Suite about diabetes management and how it's affected by the use of telehealth, especially during the current and trying times of the COVID-19 pandemic.
Listen
