A 'Global Reference' Comparator for Biosimilar Development

Area of Science:

• Biopharmaceutical development
• Regulatory science
• Comparative analytics

Background:

• Drug regulators permit using biosimilar development data from foreign-licensed reference products.
• Most authorities mandate bridging studies comparing foreign and local reference product versions.
• These repetitive bridging studies incur substantial costs for biosimilar sponsors.

Purpose of the Study:

• To propose a simplified approach for selecting reference comparators for biosimilar development.
• To eliminate the need for new bridging studies by leveraging existing data.
• To discuss the implications for biosimilar approval and interchangeability designations.

Main Methods:

• Analyzing shared development data across different jurisdictional versions of reference biologics.
• Reviewing comparability assessments for manufacturing changes between reference product versions.
• Examining successful biosimilar approvals in multiple regions as evidence.

Main Results:

• Minor analytical differences between reference biologic versions are typically clinically insignificant.
• Shared development data and rigorous comparability processes support a unified approach.
• Existing biosimilar approvals demonstrate the feasibility of using diverse reference product versions.

Conclusions:

• A simplified basis for reference comparator selection, negating bridging studies, is proposed.
• This approach reduces development costs and timelines for biosimilars.
• The proposal has significant implications for global biosimilar market access and interchangeability.