FDA Launches Video Series about Biosimilar and Interchangeable Products
May 23, 2018
The Food and Drug Administration (FDA) has released a five-part video series designed to provide an overview of biosimilar and interchangeable products and highlight key concepts about the development and approval of these products. The videos are intended to help health care professionals, patients, and other stakeholders understand what biosimilar and interchangeable products are, as well as the rigorous standards that biosimilars must meet before the FDA can approve them.
The video series covers the following topics:
- The Promise – The benefits of biosimilars.
- The Basics –Key terms and concepts about biosimilars, including why patients and health care professionals should be confident in these products.
- Interchangeability – Requirements needed to meet the standard for interchangeable products.
- The Development – The abbreviated licensure pathway and stepwise approach to demonstrating biosimilarity.
- The Data – The data, studies, and analytical tools required to demonstrate biosimilarity.
The video series is part of a larger FDA education and outreach effort about biosimilar and interchangeable products that includes materials such as fact sheets, shareable graphics, and other resources.