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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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Biosimilars in Dermatology - theory becomes reality
Sascha Gerdes1, Ulrich Mrowietz1, Matthias Augustin2
1Psoriasis-Center at the Department of Dermatology, University Medical Center Schleswig-Holstein, Campus Kiel, Germany.
Summary
Biosimilars for tumor necrosis factor alpha inhibitors are approved for dermatological use. While extrapolation of efficacy and safety data is accepted, interchangeability and switching data require careful consideration.
Area of Science:
- Dermatology
- Pharmacology
- Immunology
Background:
- Biosimilars are highly similar biological medicines to reference products.
- Tumor necrosis factor alpha inhibitor biosimilars (infliximab, etanercept) are approved for dermatological indications.
- Regulatory approval requires extensive physicochemical, functional, and clinical similarity data.
Purpose of the Study:
- To review the regulatory requirements for biosimilar approval.
- To assess the current scientific understanding of biosimilar extrapolation and interchangeability in dermatology.
- To provide recommendations on biosimilar use and documentation.
Main Methods:
- Review of regulatory guidelines for biosimilar development and approval.
- Analysis of published clinical trial data for tumor necrosis factor alpha inhibitor biosimilars.
- Evaluation of scientific literature regarding biosimilar extrapolation and switching.
Main Results:
- Biosimilar approval relies on demonstrating essential similarity to originator products through comprehensive data.
- Extrapolation of efficacy and safety data to new indications is standard regulatory practice.
- Limited data exist on the interchangeability and effects of multiple consecutive switches between originator and biosimilar products.
Conclusions:
- Current data support the use of biosimilars in dermatological indications.
- Sequential switching between biosimilars and originators warrants careful consideration due to a lack of extensive data.
- Accurate product documentation in patient registries is crucial for enhancing biosimilar evidence and confidence.
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