FDA Releases Educational Video Series on Biosimilars

Yesterday, the FDA announced the release of a 5-part video series designed to provide viewers a background of what biosimilar and interchangeable products are, the development and approval process for these products, and the tools and technologies that are used to demonstrate biosimilarity.

The video series is just the latest in a broader education and outreach effort the FDA has been conducting in regard to biosimilar and interchangeable products. Some prior education materials include fact sheets, infographics, and a stakeholder toolkit. The goal of these materials is to educate healthcare professionals, patients, and other stakeholders on what these products are as well as ensuring safety and efficacy.

Each educational video features a specific topic and answers questions about biosimilars by multiple staff members of the FDA:

• The Promise of Biosimilars: This video features FDA Commissioner, Scott Gottlieb, MD, and Leah Christl, PhD, director of the Office of New Drugs (OND) Therapeutic Biologics and Biosimilars Staff at FDA Center for Drug Evaluation and Research (CDER). Together they discuss the benefits of biosimilars.
• The Basics of Biosimilars: This video features Christl who provides an overview of biosimilars and what the FDA approval process looks like.
• The Concept of Interchangeability: This video features Christl who explains what an interchangeable product is, and the extensive research and evaluation a product would go through to achieve this distinction.
• The Biosimilar Development Process: This video features Sue Lim, MD, director of the Scientific Staff, OND Therapeutic Biologics and Biosimilars Staff at FDA CDER. Lim provides an outline of the FDA’s abbreviated licensure pathway for biosimilars.
• Analytical Data for Biosimilar Products: This video features Steve Kozlowski, MD, director of the Office of Biotechnology Products at the Office of Pharmaceutical Quality, FDA CDER. Kozlowski discusses the data, studies, and analytical tools that are required in order to demonstrate biosimilarity.

“The FDA will continue to play a prominent role in facilitating the efficient development and approval of high quality, safe, and effective biosimilar and interchangeable products,” according to the press release.

To date, the FDA has approved 10 biosimilars. The most recent approval was awarded to Pfizer’s epoetin alfa biosimilar, to be marketed as Retacrit.