Follow-on Biologics in the EU & US
By Raymond A. Huml, MS, DVM, RAC; Kamali Chance, MPH, PhD, RAC; Kevin Howe, PhD; Peter Hicks, PhD; and Ross M. Tonkens
Follow-on biologic (FOB) is the generally accepted terminology, although “biogeneric” is often favored by the generic drug industry. European and Canadian regulatory agencies refer to these biologic entities as “biosimilars.” This article summarizes the status of this rapidly evolving area in the EU and US.
Regulatory Focus 13:9-13, 2008.
