First Interchangeable Biosimilar Insulin Approved

Semglee (insulin glargine-yfgn) is a biosimilar basal insulin with the same chemical composition as insulin glargine. However, since it is a biosimilar, it is a less costly version of this widely popular basal insulin. Up until now, pharmacists could not make “pharmacy-level substitution”—much like how generic drugs are substituted for brand name drugs, without provider approval.

With this new FDA approval, an interchangeable biosimilar product may be substituted for the reference product without the intervention of the prescriber. Biosimilars marketed in the U.S. typically have launched with initial list prices 15% to 35% lower than comparative list prices of the reference products.

Bottom line, the pharmacist can now interchange or substituted semglee for its reference product Lantus (insulin glargine) without prescriber approval.

“This is a momentous day for people who rely daily on insulin for treatment of diabetes, as biosimilar and interchangeable biosimilar products have the potential to greatly reduce health care costs,” said Acting FDA Commissioner Janet Woodcock, M.D.

This also has implications for future, lower cost biosimilars says Dr. Woodcock. “Today’s approval of the first interchangeable biosimilar product furthers FDA’s longstanding commitment to support a competitive marketplace for biological products and ultimately empowers patients by helping to increase access to safe, effective and high-quality medications at potentially lower cost.”

Semglee (insulin glargine-yfgn), offered in 10 mL vials and 3 mL prefilled pens, is administered subcutaneously once daily.

Access to affordable insulin is critical and the approval of this first biosimilar heralds good news for future biosimilar interchangeability.

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