31 March 2016 - To address biosimilar labeling in particular, the FDA has issued detailed recommendations to industry in the “Labeling for Biosimilar Products” draft guidance. One of the first items health care professionals may notice in the Highlights section is the addition of a “Biosimilarity Statement” describing the biosimilar product’s relationship to its reference product.

For more details, go to: http://www.fda.gov/Drugs/NewsEvents/ucm493240.htm