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Biosimilar drugs : concerns and opportunities
Armando A Genazzani1, Giovanni Biggio, Achille Patrizio Caputi
1DiSCAFF, Department of Chemical, Food, Pharmaceutical and Pharmacological Sciences, University of Piemonte Orientale A. Avogadro, Novara, Italy.
Summary
Patents expiring for biologic agents allow for non-proprietary versions. Regulatory processes for generics do not apply to these complex biologics, necessitating distinct guidelines for biosimilars.
Area of Science:
- Biotechnology
- Pharmaceutical Science
- Regulatory Affairs
Background:
- Biologic agent patents from the 1980s are expiring.
- This creates opportunities for non-proprietary biologic versions.
- Traditional generic drug regulatory pathways are insufficient for biologics.
Purpose of the Study:
- To differentiate biologics from traditional generics.
- To examine the challenges and opportunities for biosimilars.
- To highlight issues in regulatory guideline development and clinical integration.
Main Methods:
- Comparative analysis of biologic and generic drug characteristics.
- Review of current regulatory terminology and approaches.
- Assessment of clinical and regulatory challenges.
Main Results:
- Biologics differ fundamentally from generics in size, synthesis, purification, stability, and immunogenicity.
- Terminology for non-proprietary biologics (e.g., biosimilars, follow-on biologics) is debated.
- Existing generic regulatory frameworks are inadequate for biosimilars.
Conclusions:
- Biosimilars require unique regulatory pathways distinct from generics.
- Clear guidelines are needed for biosimilar development and market entry.
- Addressing scientific and regulatory complexities is crucial for clinical adoption.
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