June 11, 2020
The following quote is attributed to Patrick Archdeacon, M.D. acting associate director for therapeutics in the Division of Diabetes, Lipid Disorders and Obesity, Office of New Drugs.
“Long-acting insulin products like insulin glargine play an important role in the treatment of types 1 and 2 diabetes mellitus, and approvals like this one highlight the FDA’s longstanding commitment to supporting a competitive marketplace for insulin products.
“Today’s approval provides patients with an additional safe and effective treatment option and also expands the number of products that are available to serve as a reference product for a proposed insulin glargine biosimilar or interchangeable biosimilar product now that the biosimilar pathway is available for insulin products following the statutory transition earlier this year.”
- Today, the U.S. Food and Drug Administration approved a new insulin product, indicated to improve glycemic control in adult and pediatric patients with type 1 diabetes mellitus and in adults with type 2 diabetes mellitus.
- Upon approval, the approved NDA was deemed to be an approved biologics license application (BLA) under section 351(a) of the Public Health Service Act and can therefore be a reference product for a proposed insulin glargine biosimilar or interchangeable biosimilar product.
- Once available, FDA-approved biosimilar and interchangeable insulin products are expected to expand competition and ultimately empower patients by increasing choices and potentially lowering prices of safe, effective, high-quality medications.
- This application was approved under section 505 of the Federal Food, Drug, and Cosmetic (FD&C) Act after the March 23, 2020, transition date pursuant to the Further Consolidated Appropriations Act, 2020 (FCA Act). The FCA Act amended the Biologics Price Competition and Innovation Act of 2009 to provide that the FDA would continue to review an application for a biological product under section 505 of the FD&C Act after March 23, 2020, so long as it meets certain requirements, and was filed on or before March 23, 2019.The FCA Act also provides that upon approval of such an application, it will be deemed to be a license for the biological product (i.e., an approved BLA).
TThe FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.