Journalartikel

Jahr der Veröffentlichung: 2015

Seiten: S5-S14

Zeitschrift: Expert Review of Clinical Immunology

Bandnummer: 11

ISSN: 1744-666X

eISSN: 1744-8409

Open Access Status: Bronze

DOI Link: https://doi.org/10.1586/1744666X.2015.1090310

Verlag: Taylor and Francis Group

Abstract: 
Biosimilars are drugs developed to be highly similar to their originator biologic (or 'reference medicinal product') with no clinically meaningful differences in purity, efficacy or safety. Production of biologics and biosimilars is highly complex and sensitive, with any change in manufacturing process having a potential impact on efficacy and safety. This review provides an overview of the manufacturing process for these drugs and considers the implications of any process changes. The scientific rationale underlying the regulatory comparability exercise for process-changed reference medicinal products and biosimilars is also discussed, as is the issue of 'switchability' from a reference medicinal product to its biosimilar. CT-P13 (Remsima (R), Inflectra (R)), a biosimilar of infliximab, is used as a case study to discuss these issues.

Harvard-Zitierstil: Mueller-Ladner, U., Hong, S., Oh, C. and Taylor, P. (2015) Scientific rationale behind the development and approval of biosimilar infliximab (CT-P13) in Europe, Expert Review of Clinical Immunology, 11, pp. S5-S14. https://doi.org/10.1586/1744666X.2015.1090310

APA-Zitierstil: Mueller-Ladner, U., Hong, S., Oh, C., & Taylor, P. (2015). Scientific rationale behind the development and approval of biosimilar infliximab (CT-P13) in Europe. Expert Review of Clinical Immunology. 11, S5-S14. https://doi.org/10.1586/1744666X.2015.1090310