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

Biological medicinal products are subject to regulations and laws established in recent years. Biologics present a challenge because the reproduction of effective therapeutic proteins is more difficult than generic drugs. As a result, biologics have certain provisions that must be met/adhered to as per the Biologics Price Competition and Innovation Act.

Learn:

• How to access FDA guidance on the development and licensure procedure for follow-on biologics.
• About the Biologics Price Competition and Innovation Act
• Biosimilarity and interchangeability
• The criteria for biosimilar licensure