Video released ahead of 2nd Annual National Policy and Advocacy Summit on Biologics and Biosimilars
WASHINGTON – Today the Alliance for Patient Access released a new video, “The Interchangeability Promise,” which examines why switching data requirements are an important part of the FDA’s draft guidance on biosimilar interchangeability. The video is released ahead of Thursday’s 2nd Annual National Policy and Advocacy Summit on Biologics and Biosimilars in Washington, DC.
The FDA describes interchangeable biosimilars as imitations that offer a nearly identical benefit as the original biologic for “any given patient.” Pharmacists will be permitted to dispense biosimilars that are approved as interchangeable in place of a patient’s prescribed biologic.
The agency’s recent draft guidance on interchangeability explains that exact data requirements may vary by product. It encourages manufacturers to communicate with the FDA about how best to demonstrate interchangeability. Yet several requirements seem certain:
- Clinical trials on the biosimilar
- Information about its biochemical make-up
- Details about its impact on patients’ immune systems
- Data on switching.
This last component is crucial, AfPA’s video argues. Patients who take a biologic or biosimilar regularly over a period of time depend upon an expected response. To date, the body of research on patients’ response to switching among biologics and biosimilars is limited. Yet the cost savings expected from biosimilars makes switching – either voluntary or imposed by health plans – likely.
FDA’s guidance requires data from “one or more switching studies.” These are clinical trials designed to demonstrate that patients are not worse off when switching than when staying on the original medication. But AfPA points to a critical and missing detail from FDA’s guidance. For a biologic that treats several different diseases, will switching data be required for each disease? If not, how dependable can the interchangeability promise be?
The video advocates for a “cautious approach” that requires “comprehensive switching study requirements.” This approach can maintain the FDA’s track record of safety and efficacy, the video concludes, ensuring that interchangeable biosimilars work for the patients who need them.
The 2nd Annual National Policy and Advocacy Summit on Biologics and Biosimilars will explore timely state and federal policy issues impacting patient access to approved biologic therapies and their biosimilar counterparts. The summit, held at the Ronald Reagan Building and International Trade Center, will feature remarks by Senator Bill Cassidy, M.D. (R-La.), FDA official Leah Christl, Ph.D, and Shannon Miller, decorated Olympic gymnast and cancer survivor. The summit begins at 9:15 a.m. on Thursday.
Alliance for Patient Access http://allianceforpatientaccess.org