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Medientyp:
E-Artikel
Titel:
Current perspectives on biosimilars
Beteiligte:
Agbogbo, Frank K;
Ecker, Dawn M;
Farrand, Allison;
Han, Kevin;
Khoury, Antoine;
Martin, Aaron;
McCool, Jesse;
Rasche, Ulrike;
Rau, Tiffany D;
Schmidt, David;
Sha, Ma;
Treuheit, Nicholas
Erschienen:
Oxford University Press (OUP), 2019
Erschienen in:
Journal of Industrial Microbiology and Biotechnology, 46 (2019) 9-10, Seite 1297-1311
Sprache:
Englisch
DOI:
10.1007/s10295-019-02216-z
ISSN:
1476-5535;
1367-5435
Entstehung:
Anmerkungen:
Beschreibung:
Abstract In this work, an overview of the biosimilars market, pipeline and industry targets is discussed. Biosimilars typically have a shorter timeline for approval (8 years) compared to 12 years for innovator drugs and the development cost can be 10–20% of the innovator drug. The biosimilar pipeline is reviewed as well as the quality management system (QMS) that is needed to generate traceable, trackable data sets. One difference between developing a biosimilar compared to an originator is that a broader analytical foundation is required for biosimilars and advances made in developing analytical similarity to characterize these products are discussed. An example is presented on the decisions and considerations explored in the development of a biosimilar and includes identification of the best process parameters and methods based on cost, time, and titer. Finally factors to consider in the manufacture of a biosimilar and approaches used to achieve the target-directed development of a biosimilar are discussed.