The FDA may require comparative clinical efficacy for biosimilar approval, but on top of all the other required and available evidence, these trials add little value, Sarfaraz K. Niazi, PhD, states.
A true biosimilar product has “no clinically meaningful difference” compared with its reference product. Given the structural variance in a biosimilar candidate and its reference product, the regulatory agencies recommend stepwise testing that comprises analytical assessment, animal pharmacology, and clinical pharmacology profiling.
Clinical safety and efficacy testing should not be allowed if there remains a residual uncertainty after the stepwise assessment. Comparative efficacy testing of biosimilars is redundant at best based on the following: