Maui Derm 2016 Highlights: Biosimilar Clinical Study Design, Extrapolation, and Interchangeability


B. Strober, MD, PhD

Is it really the same? The designs of clinical trials for biosimilars are very different from those for originator agents: sample sizes are smaller and durations are shorter. All of these studies are aimed at demonstrating equivalence between the biosimilar and the originator.

It is remarkable that approval for one indication may confer approval in all indications achieved by the reference product. The biosimilar may never be evaluated in a clinical trial before it is used in clinical practice. Given the compounds in question are far more complicated than a generic drug – it may be inappropriate for us to consider these as simply the “generics” of biologics.

Interchangeability may greatly affect your practice. This designation of a biosimilar based on additional evidence demonstrating that the biosimilar can be expected to produce the same clinical result as the reference product in any given patient. Interchangeability will support non-medical treatment changes in your patients mandated by pharmacists and payers.