While investigational products intended for use in a new formulation are more suited to placebo-controlled study design, biosimilar or “generic” products may be best suited to a non-inferiority (NI) study design, as classical bioequivalence studies are not sufficient in RRMS for the licensing of new generics. This whitepaper discusses seven key considerations for proposing an NI study design. Using relapsing remitting multiple sclerosis (RRMS) as a study case, they outline the non-negotiables, as well as the subtler implications, of these seven elements.
Authors:
Michael Murphy, MD, PhD
Chief Medical and Scientific Officer
Tom Babic, MD, PhD
Vice President, Scientific Solutions, Neuroscience
