On February 2nd, ASBM’s Chairman Harry Gewanter and its Executive Director Michael Reilly participated in a panel discussion in Brussels, Belgium. The panel was held as part of a Labelling Workshop hosted by the European Biopharmaceutical Enterprises (EBE) and EuropaBio.
Dr. Gewanter and Mr. Reilly discussed the findings of ASBM’s surveys of U.S. physicians and pharmacists, which show a desire for more informative, accurate labeling of biosimilars. In particular, providers want greater transparency regarding indication extrapolation and the source of data appearing on the label than is currently required by the U.S. FDA.
Mr. Reilly praised Health Canada’s recent SEB (biosimilar) Guidance, which requires a biosimilar’s label to show data generated by its sponsor, and provide safety data for all approved indications.