BioCentury
ARTICLE | Politics & Policy

FDA releases biosimilar labeling guidance

April 1, 2016 1:23 AM UTC

In draft Humira adalimumab from AbbVie Inc. (NYSE:ABBV).

Last year, AbbVie asked FDA to include statements on biosimilar drugs' labels clearly identifying them as biosimilars, indicating whether they are interchangeable with reference products, and describing data that support the biosimilar's approval (see BioCentury Extra, Dec. 7, 2015). ...