July 29, 2021 – The FDA has approved the first interchangeable insulin, Semglee, which can replace the much more expensive brand Lantus in the pharmacy without the need for a separate prescription.
The approval will allow Semglee to operate as a generic drug in the market and is expected to 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 type 1 or type 2 diabetes.
Originally in June 2020, Semglee is now an ‘interchangeable biosimilar’ meaning that it has no clinically significant difference from the brand name drug and can replace Lantus just like generic drugs generally are.
To be approved as an interchangeable biosimilar, manufacturers must provide additional data indicating how it can be used in the market.
These types of products, like other generics, can significantly reduce drug costs. The FDA has said other biosimilars in the United States have been launched at prices 15-35% lower than brand-name drugs.
A typical month’s supply of Semglee injection pens costs around $ 150 to $ 190 without insurance, compared to $ 340 to $ 520 for Lantus, the Associated Press reported.