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 with type 2 diabetes. It is the first interchangeable product...
The interchangeability designation means Semglee can be substituted at the pharmacy level, without physician intervention, for the reference product, Sanofi’s Lantus (insulin glargine). Such ease of substitution has long...