BioCentury
ARTICLE | Top Story

FDA's biosimilars guidances leave questions begging

April 29, 2015 12:28 AM UTC

FDA released three final guidance documents on biosimilars on Monday, but left for later its regulatory answers on requirements for demonstrating interchangeability of a biosimilar with a reference product and terms for establishing the exclusivity period for pioneer biologics.

FDA will address these issues in a separate draft guidance. Spokesperson Sandy Walsh said the agency does not have an estimated timeline for when the document will be released (see BioCentury, Feb. 13, 2012). ...