BREAKING NEWS: FDA Denies Citizen Petitions Regarding Biosimilar Labeling

Biosimilar News  •  BPCIA and Related U.S. Statutes  •  FDA Citizen Petition Tracker  •  Labeling

FDA denied citizen’s petitions from Abbvie, the UAW Retiree Medical Benefits Trust, and the Pharmaceutical Research and Manufacturers of America (“PhRMA”) and Biotechnology Industry Organization (“BIO”) trade associations requesting that FDA impose particular labeling requirements on biosimilar applicants.  FDA said it will continue to determine appropriate labeling on a case-by-case basis and invited the parties to submit comments on its draft labeling guidance.

Stay tuned to Big Molecule Watch for further analysis.

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