Semglee (insulin glargine-yfgn U-100) will be the first "interchangeable" biosimilar.
It was originally approved as a new brand of insulin glargine, not a Lantus generic...and switching required a new Rx.
Now Semglee is both biosimilar to, and interchangeable with, Lantus. Biosimilars have to show similar safety, purity, and potency as the original, or "reference," biologic.
But an "interchangeable" biosimilar also gives the same clinical result. Semglee is the first biosimilar to have this kind of evidence. It controls diabetes similar to Lantus.
Plus an interchangeable biosimilar CAN often be automatically substituted without a new Rx, like a generic.
Expect many payers to prefer Semglee...it costs about $100/vial or $150/box of 5 pens. Lantus is $280/vial or $430/5 pens...Basaglar is $330/5 pens.
But don't start automatically substituting currently available Semglee products for Lantus yet...simply due to how they were approved.
Look for the "-yfgn" suffix on NEW Semglee products coming later this year as a clue that these are interchangeable.
Use dividers in your fridge to separate Semglee products.
And check your state laws. Some still require contacting the prescriber before substituting an interchangeable biosimilar...or informing the prescriber or patient if the substitution is made.
Continue to work with your pharmacist to request a new Rx if switching Semglee or Lantus with Basaglar...which is its own brand of insulin glargine U-100.
Make sure patients don't accidentally get more than one glargine product. Doubling up could lead to dangerous drops in blood sugar.
See our FAQ, Facts About Biosimilars, for more details...plus the role of FDA's Purple Book in guiding biosimilar substitution. And get our chart, Comparison of Insulins, to see how Semglee stacks up.
- www.fda.gov/news-events/press-announcements/fda-approves-first-interchangeable-biosimilar-insulin-product-treatment-diabetes (8-24-21)
- www.fda.gov/drugs/therapeutic-biologics-applications-bla/biosimilars (8-24-21)
- https://purplebooksearch.fda.gov/ (8-24-21)
- Medication pricing by Elsevier, accessed Aug 2021