FDA Issues Guidance on Pathway for Interchangeable Biologics

The pathway is intended to help patients by making more treatment options available through biosimilar and interchangeable products.

In an effort to promote competition in the biologic market, officials with the FDA today released a final guidance on the pathway for interchangeable biosimilar products.

According to a statement released by acting FDA Commissioner Ned Sharpless, MD, the final guidance will provide clarity for developers who want to demonstrate that their proposed biological products meet the statutory interchangeability standard under the Public Health Service Act. Ultimately, the goal is to help patients by making more treatment options available.

Advancing policy to promote competition in the biosimilar market has been an ongoing goal of the FDA. Former FDA Commissioner Scott Gottlieb, MD, regularly advocated for increased biosimilar and therapeutic interchangeable competition. The agency’s Biosimilar Action Plan, released in July 2018, steered the FDA toward policy geared at bringing more biosimilars to market. To date, the FDA has already licensed 19 biosimilar products.

Included in the guidance is an overview of important scientific considerations in demonstrating interchangeability with a reference product, as well as recommendations for an application or a supplement for a proposed interchangeable product.

The information in the guidance provides clarity on the pathway for interchangeability, including:

  • Data and information needed to support a demonstration of interchangeability.
  • Considerations for the design and analysis of a switching study or studies to support a demonstration of interchangeability.
  • Considerations regarding the comparator product in a switching study or studies.
  • Abbreviated considerations for developing presentations, container closure systems, and delivery device constituent parts for proposed interchangeable products.

In the statement, Dr Sharpless also suggested that the final interchangeability guidance will help individuals with diabetes gain access to biosimilar or interchangeable insulin. This could be significant for patients with diabetes because there are no currently approved insulin products that can be substituted at the pharmacy level. Approval of these insulins can lead to increased access and lower cost for patients.

“For chronically used biologic medications patients get at the pharmacy, such as insulin, the ability to have a licensed interchangeable that can be substituted at the pharmacy without the intervention of the prescribing health care professional—much like how generic drugs are routinely substituted for brand name drugs—could be integral to the success of reducing drug prices for patients,” Sharpless said.

Additionally, the FDA will also be issuing an additional guidance on recommendations for the design and evaluation of comparative analytical studies and other important scientific considerations to support demonstration that a biological product is biosimilar to a reference product.

According to Sharpless, this data will help build the foundation for a developmental program for a proposed biosimilar or interchangeable program.

Learn more about the regulatory and legislative impact on biosimilar interchangeability here.


Statement from Acting FDA Commissioner Ned Sharpless, MD, on policy advancements to help bring interchangeable biosimilars to market [FDA statement]. FDA. https://www.fda.gov/news-events/press-announcements/statement-acting-fda-commissioner-ned-sharpless-md-policy-advancements-help-bring-interchangeable. Accessed May 10, 2019.

Related Videos
Related Content
© 2023 MJH Life Sciences

All rights reserved.