Sandoz Inc.’s application for a biosimilar version of Amgen Inc.’s Neupogen (filgrastim) not only marks the first publicly disclosed filing under the 351(k) regulatory pathway, it reflects a paradigm shift in thinking among FDA drug review staff that bodes well for other follow-on products working their way through the pipeline.
During five years of interactions with FDA over the filgrastim application, Sandoz witnessed an evolution in the mindset of clinical...