BioCentury
ARTICLE | Politics & Policy

FDA to issue biosimilar interchangeability guidance

July 1, 2015 1:41 AM UTC

In a submission to the White House Office of Management and Budget (OMB), FDA estimated it expects to receive five biosimilar product applications and two interchangeable product applications or supplements per year. The agency also said it plans to issue a draft guidance this year addressing biosimilar interchangeability entitled "Considerations in Demonstrating Interchangeability to a Reference Product."

FDA issued draft guidance last month on biosimilars; however, the document did not settle key issues on interchangeability (see BioCentury Extra, May 12). ...