BRIEF—FDA releases new video series to provide an overview of biosimilar and interchangeable products

The US Food and Drug Administration (FDA) has announced its new five-part video series, designed to provide an overview of biosimilar and interchangeable products and to highlight key concepts about the development and approval of these products, as well as how state-of-the-art technologies and tools are used to demonstrate biosimilarity.

A biosimilar is a biological product that is highly similar to, and has no clinically meaningful differences from, an existing FDA-approved reference product. To date, the FDA has approved ten biosimilars, which may help create more market competition and patient access to therapeutic biological products - many of these biosimilars treat serious and life-threatening illnesses.

The number of FDA-approved biosimilar products continues to grow.

“We want health care professionals, patients, and other stakeholders to understand what these products are and the rigorous standards that biosimilars must meet before the FDA can approve them,” the agency stated.