FDA approves first interchangeable biosimilar insulin
The FDA approved the first interchangeable biosimilar insulin product to improve glycemic control for children and adults with diabetes, part of an effort to provide cost-effective options, according to an agency press release.
Semglee (insulin glargine-yfgn, Mylan) is both biosimilar to and interchangeable with its reference product insulin glargine (Lantus, Sanofi), a long-acting insulin analogue. As Healio previously reported, Semglee was approved as a drug product under the 505(b)(2) NDA pathway and is now deemed a biologic under section 351(a), in accordance with the Biologics Price Competition and Innovation Act.
“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,” Acting FDA Commissioner Janet Woodcock, MD, said in the release. “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.”
A biosimilar is a biological product that is highly similar to, and has no clinically meaningful differences from, a biological product already approved by the FDA. An interchangeable biosimilar product may be substituted for the reference product without the intervention of the prescriber. The substitution may occur at the pharmacy, a practice commonly called pharmacy-level substitution, subject to state pharmacy laws, which vary by state. In the release, the FDA noted that biosimilars marketed in the U.S. typically have launched with initial list prices 15% to 35% lower than comparative list prices of the reference products; however, experts have debated whether biosimilar insulin products will substantially lower cost to patients.
“Access to affordable insulin is critical, and long-acting insulin products, like insulin glargine, play an important role in the treatment of types 1 and 2 diabetes mellitus,” Peter Stein, MD, director of the Office of New Drugs in the FDA’s Center for Drug Evaluation and Research, said in the release. “The FDA’s high standards for approval mean health care professionals and patients can be confident in the safety and effectiveness of an interchangeable biosimilar product, just as they would for the reference product.”
Semglee is available in 10 mL vials and 3 mL prefilled pens and is administered subcutaneously once daily. Dosing of Semglee, like Lantus, should be individualized based on the patient’s needs and should not be used during episodes of hypoglycemia or for patients with hypersensitivity to insulin glargine products.
The approval for biosimilar insulin glargine was based in part on the INSTRIDE studies, which confirmed the pharmacokinetics, pharmacodynamics, efficacy, safety and immunogenicity of Semglee compared with Lantus for people with type 1 and type 2 diabetes. Mylan announced the U.S. launch of Semglee in August 2020, noting in a press release at the time that it was seeking an interchangeability designation from the FDA.
The launch came after favorable judgments on all remaining patent claims asserted by Sanofi against Mylan's insulin glargine products.
“Although Sanofi may seek certain appeals of those judgments, Mylan is confident they will not affect commercialization,” the company stated in their release.
In March 2020, the FDA announced the formal transition of insulin and certain other biologic drugs to a new regulatory pathway that will better facilitate the development of biosimilar or interchangeable products. In an agency statement, FDA stated that a small subset of biological products approved under the Federal Food, Drug and Cosmetic Act, such as insulin and human growth hormone, will transition to being officially regulated as biological products, enabling these drugs to serve as the reference product for biosimilar or interchangeable drugs approved through the abbreviated licensure pathway. Prior to this change, the FDA required any follow-on insulins to be approved under the abbreviated new drug pathway; these insulins were not considered to be biosimilar because insulins were approved and regulated as chemical drugs.
The FDA released new materials for health care providers to enhance understanding about biosimilar and interchangeable biosimilar products, including a fact sheet about interchangeable biosimilar products, according to the agency.