This week, the U.S. Food and Drug Administration (FDA) approved Semglee® (insulin glargine-yfgn) as the first ever interchangeable biosimilar insulin product. Semglee® (insulin glargine-yfgn) is indicated to improve glycemic control in adults and pediatric people with type 1 and adults with type 2 diabetes, and is biosimilar and interchangeable to Lantus®, a long-acting insulin.
In other words, the FDA has determined that Semglee® (insulin glargine-yfgn) is “highly similar to and has no clinically meaningful differences” to Lantus. Specifically, it may now be substituted for the prescribed reference product (Lantus) at the pharmacy counter in much the same way generic drugs are substituted for brand name drugs.
Semglee® (insulin glargine-yfgn) is not only the first biosimilar insulin, it is also the first biosimilar ever to be designated as interchangeable by the FDA.
What is a Biosimilar?
Breakthrough T1D has long encouraged FDA to make biosimilar and interchangeable insulins available. In March 2020, the FDA revised the regulatory pathway for insulin, which opened the door for this change. After review, the FDA determined that Semglee® (insulin glargine-yfgn) has “no clinically meaningful differences” to Lantus, meaning individuals who take Semglee® (insulin glargine-yfgn) can expect it to have the same safety and efficacy as Lantus.
How Will This Affect the T1D Community?
This approval has several ramifications for the T1D community. FDA has stated that they believe this decision will give people access to safe and effective insulins at a potentially lower cost.
Additionally, people with T1D who are prescribed Lantus by their physician may receive Semglee® (insulin glargine-yfgn) from their pharmacy instead because of this decision. We encourage all people with T1D to discuss their options with their physician.
Breakthrough T1D Remains Committed to Access and Affordability
JDRF strongly believes that every person with T1D should have access to the therapies that work best for them—including insulin. Interchangeable biosimilars will give people with T1D more choices for managing their T1D. Breakthrough T1D commends the FDA for its commitment to creating a competitive insulin marketplace, and will continue to urgently push for more actions from manufacturers, health plans, and the government to lower the cost of insulin.
Learn more at the FDA’s press release.
