FDA Publishes Final Rule on New Regulatory Pathway Shift for Insulin, Other Biologics

Country: UNITED STATES | Region: NORTH AMERICA | Type: Policy | Keywords: #biologicdrugs #biosimilar #fda #insulin #regulation

PRICENTRIC BRIEF:

  • On March 23, 2020, an application for a biological product approved under the Federal Food, Drug, and Cosmetic Act (FD&C Act), including applications for insulin and other biological products, will be deemed to be a license for the product under the Public Health Service (PHS) Act
  • For the first time, applications for products that are proposed as biosimilar to, or interchangeable with, the transitioned products will be allowed to be submitted—thus, the transition of insulin products from approved drug applications to deemed biological product licenses will open up those products to potential biosimilar and interchangeable competition
  • Stephen M. Hahn, FDA Commissioner, said, “This transition will open new pathways for manufacturers to bring biosimilar and interchangeable versions of insulin and other transitioning products to market, facilitating greater competition in the marketplace”

 

THE DETAILS

WASHINGTON, D.C., The United States – The U.S. Food and Drug Administration (FDA) has taken additional regulatory steps, including publishing a final rule, to increase patient access to insulin products and certain other biological products.

On March 23, 2020, an application for a biological product approved under the Federal Food, Drug, and Cosmetic Act (FD&C Act), including applications for insulin and other biological products, will be deemed to be a license for the product under the Public Health Service (PHS) Act.

For the first time, applications for products that are proposed as biosimilar to, or interchangeable with, the transitioned products will be allowed to be submitted—thus, the transition of insulin products from approved drug applications to deemed biological product licenses will open up those products to potential biosimilar and interchangeable competition.

The final rule, “Definition of the Term ‘Biological Product,’” amends the FDA’s regulation that defines “biological product” to incorporate changes made by the Biologics Price Competition and Innovation Act of 2009 (BPCI Act) and the Further Consolidated Appropriations Act, 2020, and to codify the FDA’s interpretation of the statutory term “protein.”

Specifically, under this interpretation, which is intended to clarify the statutory framework under which such products are regulated, the term “protein” means any alpha amino acid polymer with a specific, defined sequence that is greater than 40 amino acids in size.

With this finalized rule, the FDA anticipates that the availability of approved biosimilar and interchangeable insulin products will increase patient access, adding more choices and potentially reducing costs of insulin products.

FDA Commissioner Stephen M. Hahn said, “This transition will open new pathways for manufacturers to bring biosimilar and interchangeable versions of insulin and other transitioning products to market, facilitating greater competition in the marketplace.

“These critical therapies often carry a heavy price tag; the cost of insulin has risen over the past decade. Opening these products to increased competition is expected to bring down prices and help patients have access to more choices for these life-saving drugs. We will continue to communicate relevant information, including the resources we’ve issued today, to make the transition from one statutory framework to another as seamless as possible.”

To read the FDA’s new rule, please use the following link: https://www.federalregister.gov/documents/2020/02/21/2020-03505/definition-of-the-term-biological-product

 

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