BioSimilar FDA: Biosimilars Labeling Guidance Thomas Sullivan Apr 6, 2016 0 After several delays the FDA has finally released its draft guidance that says a biosimilar's label does not have to be…
BioSimilar Update on Biosimilars US Regulation 1st Quarter 2016 Thomas Sullivan Apr 6, 2016 1 Yesterday the FDA approved Inflectra the Pfizer/Celltrion version of Remicade, becoming the second biosimilar and the…
