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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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Interchangeability of Biosimilars: A European Perspective
Pekka Kurki1, Leon van Aerts2, Elena Wolff-Holz3
1Finnish Medicines Agency, FIMEA, Mannerheimintie 103b, P.O. Box 55, 00034, Helsinki, Finland. pekka.kurki@fimea.fi.
Summary
Biosimilar medicines approved in the EU are interchangeable. Switching between a reference biological medicine and its biosimilar is not expected to increase immunogenicity or affect safety and efficacy.
Area of Science:
- Biotechnology
- Pharmacology
- Immunology
Background:
- Blockbuster biological medicines face biosimilar competition in the EU.
- Biosimilarity relies on the comparability concept, proven effective for manufacturing changes.
- Extensive experience shows successful replication of complex biotechnology-derived proteins.
Purpose of the Study:
- To explore the theoretical risks of switching between reference biologicals and biosimilars.
- To analyze available data regarding patient switches between these products.
- To address concerns about immunogenicity and interchangeability.
Main Methods:
- Review of the theoretical basis for immunogenicity risks associated with switching.
- Analysis of existing data on patient switches between reference products and biosimilars.
- Evaluation of EU regulatory standards for biosimilar approval.
Main Results:
- Switching between comparable biological medicines approved in the EU is not expected to increase immunogenicity.
- Current knowledge suggests no significant difference in safety or efficacy for individuals upon switching.
- Population-level comparability supports individual-level safety and efficacy.
Conclusions:
- Biosimilar medicines licensed in the EU are considered interchangeable with their reference products.
- Concerns regarding immunogenicity upon switching are not substantiated by current evidence.
- EU-approved biosimilars offer safe and effective treatment options.
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