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Ensuring the Consistency of Biosimilars
Isabel Andujar Perez1,2,3, Ana Blas-Garcia1,3,4, Loreto Carmona5
1Departamento de Farmacologia, Facultad de Medicina, Universitat de Valencia, Valencia, Spain.
Current Pharmaceutical Design
|December 6, 2017
Summary
Manufacturing changes in biological products, like TNF-α blockers, require rigorous evaluation to ensure molecular consistency. Regulatory agencies must provide updated quality data for biologics and biosimilars to maintain confidence.
Area of Science:
- Pharmacology
- Biotechnology
- Regulatory Science
Background:
- Biological products undergo continuous regulatory review post-market.
- Manufacturing process improvements can alter fundamental molecular properties.
Purpose of the Study:
- To review the impact of manufacturing changes on biological drugs, particularly TNF-α blockers and their biosimilars.
- To assess the long-term consistency of biologics and biosimilars after initial approval.
Main Methods:
- A narrative review of scientific literature.
- Analysis of legal documents from regulatory agencies.
Main Results:
- Evaluating manufacturing changes necessitates risk-proportional analyses of molecular micro-heterogeneity.
- Over 30 TNF-α blocker biosimilars exist, each with unique manufacturing processes.
- Successive manufacturing changes may widen the gap between evolved biologics and their biosimilars.
Conclusions:
- Regulatory agencies should provide accessible, updated quality data for biologics and biosimilars.
- Ensuring post-approval consistency is crucial for maintaining practitioner and patient confidence in these complex drugs.
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