I recently presented a webinar on the Opportunities and Implications of Biosimilars & the new FDA Guidelines hosted by Pharmalot. The FDA guidance passed in February puts a new paradigm on how drug manufacturers will develop products and compete commercially for the few patients in each disease indication. There will be unique rules based on the guidelines, so the question of safety and interchangeability will have resounding implications on the commercial model, requiring expensive clinical evidence and adjudication.
