Viatris (NSDQ:VTRS) and Biocon Biologics announced FDA clearance for their Semglee insulin glargine-yfgn injection as a biosimilar.
Semglee holds an indication for controlling high blood sugar in adults with type 2 diabetes and pediatric patients with type 1 diabetes. The FDA approved Semglee as the first interchangeable biosimilar product under the 351(k) regulatory pathway. The product is sold in a pre-filled disposable pen.
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