FDA biosimilars labeling policies in flux

FDA has informed AbbVie Inc. (NYSE:ABBV) that it is unable to respond to the company's request that the agency change its policy for labeling biosimilar drugs. AbbVie filed a Citizen's Petition requesting that FDA include statements on biosimilar drugs' labels clearly identifying them as biosimilars, indicating whether a biosimilar has been designated as interchangeable with its reference product, and describing the data used to support the biosimilar's approval.

In an interim (see BioCentury Extra, Aug. 27). ...