FDA nod for first Interchangeable insulin product, Semglee

The US Food and Drug Administration approved the first interchangeable biosimilar insulin product, Semglee (insulin glargine-yfgn), from Mylan, a company that morphed into Viatris (Nasdaq: VTRS) as a result of its merger with Pfizer’s generics and biosimilars business, Upjohn, and whose shares rose 3.3% to $14.70 on the news.

Semglee is both biosimilar to and interchangeable with Lantus (insulin glargine), which is marketed by Sanofi (Euronext: SAN), and generated first-half 2021 sales of 1.29 billion euros ($1.52 billion) for the French firm.

As an interchangeable biosimilar product, Semglee) may be substituted for Lantus at the pharmacy-level without the intervention of the prescribing health care provider, subject to state pharmacy laws.