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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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Differentiating biosimilarity and comparability in biotherapeutics.
Valderilio Azevedo1, Brian Hassett2, João Eurico Fonseca3
1Federal University of Paraná, Curitiba, PR, Brazil.
Clinical Rheumatology
|October 14, 2016
Summary
Manufacturing changes to originator biologics require comparability assessments to ensure quality, safety, and efficacy. This differs from biosimilarity assessments, which evaluate a new biologic
Area of Science:
- Biopharmaceutical Manufacturing
- Regulatory Science
- Drug Development
Background:
- Biologic manufacturing involves complex, multi-step processes.
- Planned manufacturing changes in licensed biologics necessitate regulatory oversight.
- Comparability assessments ensure post-change product quality, safety, and efficacy.
Purpose of the Study:
- To clarify the distinction between comparability assessments for originator biologics and biosimilarity evaluations.
- To examine the regulatory rationale for these distinct approval pathways.
- To highlight the global application of comparability principles in biosimilar guidelines.
Main Methods:
- Review of regulatory guidance documents from FDA, EMA, and WHO.
- Analysis of the scientific and regulatory principles underlying comparability and biosimilarity.
- Comparative examination of approval processes for manufacturing changes versus new biosimilar products.
Main Results:
- Comparability assessments focus on maintaining the quality, safety, and efficacy of an existing biologic after manufacturing changes by the same manufacturer.
- Biosimilarity evaluations assess a new biologic's high degree of similarity to a reference product.
- Regulatory agencies globally incorporate comparability concepts into biosimilarity frameworks.
Conclusions:
- Comparability and biosimilarity represent distinct regulatory processes with different objectives and scopes.
- Understanding these distinctions is crucial for biopharmaceutical development and regulatory compliance.
- Both processes aim to ensure the availability of safe and effective biologic medicines.
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