Robinson Bradshaw

Topic: H.R. 3590

Follow-on Biologics: How Much Incentive Do We Need?

After almost a full year of debate, a pathway for approving “follow-on biologics” or “biosimilars” continues to be a hot topic in Congress. We are all familiar with generic versions of brand-name drugs, and the federal regulatory scheme sets out well-defined shortcut procedures for approval of generics. Congress is now grappling with designing procedures for […]