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

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

Approximate Course Time: 30 minutes

Level: Introductory/Intermediate

CPD Points: 0.5

Audience: Regulatory

Category: Regulatory Submissions

Region: USA

Who will benefit from this module?

This module will mainly benefit regulatory affairs staff concerned with the licensure of follow-on biological products.

Learning objectives

  • Outline the provisions of the Biologics Price Competition and Innovation Act
  • Identify criteria for licensure of a follow-on biologic as biosimilar or interchangeable
  • Specify periods of market exclusivity applicable to biological medicinal products
  • Outline patent infringement issues relevant to biological medicinal products
  • Access FDA guidance on development and licensure of follow-on biologics
  • Outline the provisions of the Biosimilar User Fee Act

Module outline

See details for this short course under “Learning Objectives”.

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