ARTICLE | Politics & Policy
Final interchangeability guidance allows non-U.S.-licensed comparators
May 10, 2019 6:21 PM UTC
FDA has released its final guidance on the interchangeability of biosimilars with one notable change from the draft version: sponsors may now use data from non-U.S.-licensed comparator products to demonstrate interchangeability.
The agency said sponsors should provide adequate data to establish a “bridge” between the non-U.S.-licensed comparator and the U.S.-licensed product...