FDA releases guidance on labeling for biosimilars

April 4, 2016

On April 4 2016, FDA released their much anticipated guidance on Labeling for Biosimilar Products.

The draft guidance asserts that including data from biosimilarity studies will not be useful for health care practitioners, and that a description of the clinical data that supported the safety and efficacy of the reference product should be included instead.

Comments will be accepted on this draft guidance until June 3rd, 2016.