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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
Comparative testing and pharmacovigilance of biosimilars
Francesco Locatelli1, Simon Roger
1Department of Nephrology and Dialysis A. Manzoni Hospital, Via Dell'Eremo 9/11, 23900 Lecco, Italy. f.locatelli@ospedale.lecco.it
Summary
Biosimilar analytical methods require further development for accurate quality, safety, and efficacy assessment. International standards and consistent laboratory practices are crucial for reliable biosimilar comparability and similarity testing.
Area of Science:
- Biopharmaceutical analysis
- Drug regulatory science
Background:
- Biosimilars aim to replicate complex, high-molecular-weight protein structures.
- Manufacturing process variations can impact biosimilar product safety and efficacy.
- European Agency for the Evaluation of Medicinal Products (EMEA) guidelines mandate extensive comparability testing.
Purpose of the Study:
- To examine the quality and limitations of analytical methods used for biosimilar comparability and similarity assessment.
- To discuss analytical tests for protein content, activity, integrity, stability, impurities, additives, and immunogenicity.
- To highlight the need for improved assays and international standards in biosimilar evaluation.
Main Methods:
- Review of existing analytical assays for physicochemical and biological properties.
- Assessment of comparability testing between production batches.
- Evaluation of similarity testing against a reference product.
Main Results:
- Multiple analytical assays exist for assessing biosimilar quality attributes.
- Current assays have limitations in fully demonstrating biosimilar safety and efficacy.
- Lack of international standards and differing laboratory methods hinder result comparability.
Conclusions:
- Reliable safety and efficacy assays for biosimilars are still under development.
- Clinical trials and post-authorization pharmacovigilance are essential for long-term safety assurance.
- Pharmacovigilance, including consistent manufacturing testing, is vital for risk management.
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