On May 19th, ASBM submitted comments on the FDA’s Draft Guidance Considerations in Demonstrating Interchangeability With a Reference Product. The comments may be read in their entirety below, or are available here as a PDF. May 22, 2017 Division of Dockets Management (HFA-305)here. Food and Drug Administration Department of Health and Human Services […]
In this video, ASBM’s Advisory Board Chairman Philip Schneider, Associate Dean of the University of Arizona College of Pharmacy; and Advisory Board Member Ronald Jordan, Dean of the Chapman University School of Pharmacy discuss the role of pharmacists with respect to biosimilars.
On Friday, April 21st, the FDA approved its fifth biosimilar, Renflixis (infliximab-abda). While the second biosimilar approved for Remicade (infliximab)- the first being Inflectra (infliximab-dyyb), approved in April 2016. Renflexis is noteable as the first biosimilar to be approved without a meeting of an FDA Advisory Committee. Advisory committees provide FDA with independent opinions and […]