In Focus: Follow-on Biologics

Biogenerics, biosimiliars, followon biologics…. regardless of how people in the healthcare community refer to these medicinal biological products, most have strong views and opinions regarding the need for them, how they should be regulated and their marketing approval criteria. In fact, in 2007, several pieces of legislation were proposed and subsequently debated in the US as part of the Prescription Drug User Fee Act reauthorization process. The debate will continue since Congress did not pass any of the proposed legislation. It is clear that new legislation will be introduced in 2008, and most anticipate Congress will provide FDA with a regulatory pathway for follow-on biologics review and approval.