July 29, 2021 -- The FDA has approved the first interchangeable insulin, Semglee, which can be substituted for the much more expensive brand name Lantus at the pharmacy without the need for a separate prescription.
The approval will allow Semglee to function like a generic drug in the market and should reduce insulin costs. Under the new rule, a pharmacist could recommend Semgless instead of Lantus without a doctor’s approval.
Semglee is for patients with either type 1 or type 2 diabetes.
<p>Originally in June 2020, Semglee is now an "interchangeable biosimilar," meaning that it has no clinically meaningful difference from the brand name drug and may be substituted for Lantus, just as generic drugs typically are
To be approved as an interchangeable biosimilar, manufacturers must provide additional data that shows how it may be used in the marketplace.
These types of products, like other generics, may significantly reduce drug costs. The FDA said other biosimilars in the U.S. launched with prices 15% to 35% lower than brand name drugs.
A typical month's supply of Semglee injector pens cost about $150 to $190 without insurance, compared to $340 to $520 for Lantus, The Associated Press reported.