SUB14: The Regulatory Pathway to Licensure of Follow-on Biologics (Biosimilars) in the USA

Description

The regulation of biological medicinal products is governed by different laws from those that apply to small-molecule synthetic drugs. Producing faithful copies of therapeutic proteins is more challenging than producing generic drugs. The US legal framework for the licensure of follow-on biologics, and accompanying regulatory guidance from the Food and Drug Administration (FDA), have been established only in recent years.

We describe the provisions of the Biologics Price Competition and Innovation Act, identify criteria for licensing a follow-on biologic as ‘biosimilar’ or ‘interchangeable’, specify periods of market exclusivity that apply, and discuss patent infringement issues.

Finally, we describe the provisions of the Biosimilar User Fee Act, which authorises the FDA to collect fees from follow-on biologics sponsors, to support review activities