EU Marketing Authorization Requirements for Biosimilar Medicines

"The European Union (EU) has outlined the regulatory framework and procedural requirements for biosimilar applications to ensure they meet the same standards as reference products.

Key Requirements:

• Comparability Assessment: Demonstrating similarity in quality, safety, and efficacy to the reference product.
• Application Modules:
• Module 1: Administrative information & legal basis for submission.
• Module 2: Quality Overall Summary (QOS), Non-Clinical Overview, and Clinical Overview.
• Module 3: Detailed quality comparability exercise.
• Module 4 & 5: Pre-clinical & clinical studies supporting biosimilarity.
• Risk Management Plan (RMP): Ensuring post-market safety monitoring.
• User Consultation: Evaluation of package leaflet readability for patients.
• The framework ensures biosimilars uphold EU regulatory standards, offering safe and effective alternatives to reference biologics.

Region: European Union

Source: https://www.ema.europa.eu/en/human-regulatory-overview/marketing-authorisation/biosimilar-medicines-marketing-authorisation