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In Vitro Methods for Comparing Target Binding and CDC Induction Between Therapeutic Antibodies: Applications in Biosimilarity Analysis
Published on: May 4, 2017
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[Biosimilars, the journey has begun].
Alba Martos-Rosa1, Juan Enrique Martínez-de la Plata1, Jose Antonio Morales-Molina1
1Servicio de Farmacia Hospitalaria. Hospital de Poniente, El Ejido, Almería. España.. alba.martos@ephpo.es.
Summary
Biosimilar medicines are biological products similar to reference medicines, requiring rigorous comparability assessments. Their introduction enhances competition and patient access to advanced therapies.
Area of Science:
- Pharmacology
- Biotechnology
- Regulatory Science
Background:
- Biosimilars are biological medicines highly similar to authorized reference products.
- Proving biosimilarity requires comprehensive comparability, unlike generic drugs.
- Biopharmaceuticals can elicit a stronger immune response than conventional medicines.
Purpose of the Study:
- To define biosimilarity and regulatory considerations within the European Economic Area.
- To highlight the differences in evaluation between biosimilars and generic drugs.
- To discuss the implications of biosimilar market entry on competition and patient access.
Main Methods:
- Review of European Medicine Agency guidelines on biosimilar evaluation.
- Analysis of the scientific basis for biosimilar comparability assessments.
- Examination of regulatory frameworks and pharmacovigilance requirements.
Main Results:
- Biosimilarity is established through extensive quality, biological activity, safety, and efficacy comparisons.
- Standard bioequivalence studies are insufficient for complex biotechnology-derived products.
- Interchangeability and substitution policies are determined at the EU member state level.
Conclusions:
- Biosimilar evaluation demands a rigorous comparability approach due to product complexity.
- Clear identification and pharmacovigilance are crucial for biosimilar medicines.
- The European regulatory framework for biosimilars has evolved, promoting competition and access to biological therapies.
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