Now approved as an interchangeable biosimilar, US labeling for Viatris’ insulin aspart mirrors that of Sanofi’s Lantus and has shed data from two studies in type 1 and 2 diabetics that showed noninferiority to Sanofi’s Lantus; Viatris appears in line for one year of exclusivity.
Viatris Inc.’s Semglee (insulin glargine-yfgn) became the first biosimilar insulin – and the first interchangeable biologic product – in the US with the Food and Drug Administration’s 28 July approval, but lost its labeling on product-specific clinical efficacy and safety data in the process.
The FDA approved Semglee to improve glycemic control in adults and pediatric patients with type 1 diabetes and in adults...
The International Council for Harmonisation has identified four new topics that can benefit from global regulatory alignment, with timelines for initiating work to be determined later.
Deputy FDA Commissioner Grace Graham acknowledged the importance of user fees, while also calling for restructuring. She also said part of MAHA's mission is to reexamine uses of drugs not supported by data.
Pharmaceutical industry organizations offered alternatives to tariffs that could maintain a secure domestic supply chain in public comments filed in response to a federal 232 investigation.
