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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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Biological agents and biosimilars: Essential information for the internist
Luca Pasina1, Gianluigi Casadei1, Alessandro Nobili1
1IRCCS Istituto di Ricerche Farmacologiche Mario Negri, Milan, Italy.
European Journal of Internal Medicine
|June 26, 2016
Summary
Biosimilars are highly similar to originator biologics, offering comparable safety and efficacy. Rigorous development ensures they provide a similar risk-benefit balance for patients.
Area of Science:
- Biotechnology
- Pharmacology
- Immunology
Background:
- Biologics are complex substances produced by living organisms.
- Biosimilars are highly similar to reference biologic drugs.
- Development costs and market access are key considerations.
Purpose of the Study:
- To explain the scientific principles of biosimilars.
- To address clinician concerns regarding biosimilars.
- To highlight the regulatory pathway for biosimilars in the EU.
Main Methods:
- Comprehensive comparability assessment.
- Review of available evidence and pharmacovigilance data.
- Explanation of the European Medicines Agency (EMA) biosimilar pathway.
Main Results:
- Biosimilars demonstrate similarity in quality, activity, safety, and efficacy.
- No clinical alerts indicate increased risk compared to originators.
- The EMA pathway ensures a comparable risk-to-benefit balance.
Conclusions:
- Clinicians should be confident in the safety and efficacy of biosimilars.
- The development and regulatory process ensures biosimilars are safe and effective.
- Biosimilars offer a sustainable option for healthcare systems.
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