Washington, DC—The approval of the first interchangeable biosimilar insulin product by the FDA is expected to have some effect on insulin costs in the United States.

The FDA points out that Semglee (insulin glargine-yfgn) is both biosimilar to, and interchangeable with, its reference product Lantus (insulin glargine), a long-acting insulin analog. “Semglee (insulin glargine-yfgn) is the first interchangeable biosimilar product approved in the U.S. for the treatment of diabetes,” the agency said in a press release. “Approval of these insulin products can provide patients with additional safe, high-quality and potentially cost-effective options for treating diabetes.”

Mylan advises that it is offering Semglee at a wholesale acquisition cost (WAC) of $147.98 per package of five 3-ml pens and $98.65 per 10-ml vial, representing the lowest WAC for any long-acting insulin glargine on the market.

In fact, the list price of Semglee pen is equivalent to the Lantus launch price in 2007, with the Semglee vial listed at Lantus’s 2010 pricing. Patient assistance and/or a copay card will also be available to qualified users.

“We are proud to be the first company, following the reference product, to receive FDA approval on and launch both the vial and pen presentations of an insulin glargine treatment with an identical amino acid sequence to Sanofi’s Lantus,” said Mylan CEO Heather Bresch. “Even more importantly, we are proud to make Semglee available to the more than 30 million Americans living with diabetes in the U.S., providing more treatment options and increasing access. While providing our product at the most competitive list price on the market is an important step toward ensuring that those who need insulin are able to access and afford it, we also know that there is still work to be done to ensure this access and affordability reaches patients at the pharmacy counter.”

The product is indicated to improve glycemic control in adults and pediatric patients with type 1 diabetes mellitus and in adults with type 2 diabetes mellitus.

“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,” pointed out Acting FDA Commissioner Janet Woodcock, MD. “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.”

The FDA adds that biosimilar and interchangeable biosimilar products potentially could reduce healthcare costs, noting that biosimilars marketed in the U.S. usually launch with initial list prices 15% to 35% lower than comparative list prices of the reference products.

FDA approval is based on evidence that the products are highly similar and that they have no clinically meaningful differences in terms of safety, purity, and potency (safety and effectiveness). Studies indicated that Semglee can be expected to produce the same clinical result as Lantus in patients without greater risk.

Semglee is offered in 10-mL vials and 3-mL prefilled pens and administered SC once daily. Dosing is individualized, like Lantus, based on the patient’s needs and is not to be used during episodes of hypoglycemia or in patients with hypersensitivity to insulin glargine products; it also is not recommended for treating diabetic ketoacidosis.

The FDA also released new materials for healthcare providers to enhance understanding about biosimilar and interchangeable biosimilar products, including a fact sheet about interchangeable biosimilar products.

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