Analysis of FDA-Licensed Biosimilars: Time for a Paradigm Shift
July 11th 2020
By Sarfaraz K. Niazi, PhD
ArticleNow is the time for the FDA to lead again in revising the biosimilar development guidance by eliminating all animal toxicology studies, and replacing them with larger-species pharmacokinetic (PK) studies, allowing the conduct of human PK studies using novel clinical protocols to combine the PK/pharmacodynamic/immunogenicity testing in a single study, and, where possible, avoid these studies if an in-silico approach can provide the confidence of pharmacologic similarity.