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Updated: Feb 14, 2026
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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 der Dermatologie - Theorie wird Realität
Sascha Gerdes1, Ulrich Mrowietz1, Matthias Augustin2
1Psoriasis-Zentrum in der Hautklinik des Universitätsklinikums Schleswig-Holstein, Campus Kiel.
Summary
Biosimilars, Nachbildungen von Originalpräparaten, sind für dermatologische Indikationen verfügbar. Eine mehrmalige Umstellung sollte sorgfältig erwogen werden, und die Dokumentation jedes Patientenprodukts ist entscheidend.
Area of Science:
- Biopharmazeutika und Medikamentenentwicklung
- Dermatologie und Immunologie
Background:
- Biosimilars sind biologische Medikamente, die spezifischen Referenzprodukten ähneln.
- Tumornekrosefaktor-alpha-Inhibitoren wie Infliximab und Etanercept sind als Biosimilars für dermatologische Anwendungen zugelassen.
Purpose of the Study:
- Bewertung der Zulassungsanforderungen und der Evidenz für Biosimilars in der Dermatologie.
- Diskussion der Extrapolation von Indikationen und der Austauschbarkeit von Biosimilars.
Main Methods:
- Analyse der regulatorischen Anforderungen für Biosimilars, einschließlich physikochemischer und klinischer Daten.
- Überprüfung der wissenschaftlichen Erkenntnisse zur Wirksamkeit und Sicherheit von Biosimilars.
Main Results:
- Biosimilars erfordern eine eingehende Analyse und klinische Studien, um die Gleichwertigkeit mit dem Originalpräparat nachzuweisen.
- Die Extrapolation von Indikationen ist etabliert, aber Daten zur Austauschbarkeit und zu wiederholten Umstellungen sind begrenzt.
Conclusions:
- Die Anwendung von Biosimilars in der Dermatologie ist wissenschaftlich unbedenklich.
- Eine sorgfältige Überlegung ist bei wiederholten Umstellungen auf Biosimilars geboten, und die genaue Dokumentation der Patientenprodukte ist für das Vertrauen unerlässlich.
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