On 24 April 2024, the FDA released an updated draft guidance document on the marketing of prescription biological reference products, biosimilar products, and interchangeable biosimilar products seeking input from industry by 25 June 2024.
The revised guidance largely maintains the content from the 2020 version but seeks to “addresses questions firms may have when developing FDA-regulated promotional labeling and advertisements (promotional communications) for prescription reference products licensed under section 351(a) of the Public Health Service Act (PHS Act) (42 U.S.C. 262(a)) and prescription biosimilar products, including interchangeable biosimilar products, licensed under section 351(k) of the PHS Act (42 U.S.C. 262(k))”.
Comments on the draft guidance can be submitted here until 25 June 2024.