Clinical comparability and European biosimilar regulations.
Schellekens
Huub
H
Huub Schellekens is in the Departments of Pharmaceutical Sciences and Innovation Studies, Utrecht University, Utrecht, The Netherlands. h.schellekens@uu.nl
Moors
Ellen
E
D001702:Biopharmaceutics / Q000331:legislation & jurisprudence*; D004353:Drug Evaluation, Preclinical; D056736:Drug Recalls; D005060:Europe; D005062:European Union; D006801:Humans; D007880:Legislation, Drug