CMC, Preclinical and Clinical Considerations for Biosimilars and Follow-on Biologics
By Raymond A. Huml, MS, DVM, RAC; Peter Hicks, PhD; Kamali Chance, MPH, PhD, RAC; Kevin Howe, PhD; and Ross M. Tonkens
This article summarizes some of the issues pertaining to biosimilars in Europe that are also likely to impact eventual FOB approval testing in the US. It focuses on the key parts of the development package for an FOB marketing application, including the comparability protocol exercise and regulatory authorities’ preclinical and clinical expectations.
Regulatory Focus 13:20-23, 26-27, 2008.
