Generics, chemisimilars and biosimilars: is clinical testing fit for purpose?
British Journal of Clinical Pharmacology, 06/01/2012
Warren JB – Though there may be no detectable difference between the test and reference on clinical testing, many of the outcome measures are insensitive to even large differences in dose. For testing to be fit for purpose it should distinguish important dose differences, but many clinical tests of chemisimilars and biosimilars do not. As pharmacokinetic and pharmacodynamic technology advances the trend of replacing dose insensitive clinical trial data with equivalence tests that show assay sensitivity can be expected to continue.