AbbVie Challenges FDA Biosimilar Labeling
The AbbVie petition requests that FDA require that the approved prescription drug labeling for biological products licensed under section 351(k) of the PHSA contain:
- A clear statement that the product is a biosimilar, that the biosimilar is licensed for fewer than all the reference product’s conditions of use (if applicable), and that the biosimilar’s licensed conditions of use were based on extrapolation (if applicable);
- A clear statement that FDA has not determined that the biosimilar product is interchangeable with the reference product (if applicable); and
- A concise description of the pertinent data developed to support licensure of the biosimilar, along with information adequate to enable prescribers to distinguish data derived from studies of the biosimilar from data derived from studies of the reference product.
There is an open docket, FDA-2015-P-2000, while FDA considers the petition submitted June 2, 2015.