Current perspectives on biosimilars
Autor: | Jesse McCool, Antoine Khoury, David Schmidt, Aaron Martin, Kevin Han, Dawn M Ecker, Tiffany D Rau, Allison J. Farrand, Nicholas A. Treuheit, Frank K. Agbogbo, Ma Sha, Ulrike Rasche |
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Rok vydání: | 2019 |
Předmět: |
Computer science
Process (engineering) Fermentation Cell Culture and Bioengineering - Review media_common.quotation_subject Bioengineering Applied Microbiology and Biotechnology Microbial Innovator Animals Humans Quality (business) Biosimilar Pharmaceuticals Drug Approval media_common Biosimilars Mammalian Timeline Biosimilar Analytical Quality Pipeline (software) Manufacturing Identification (information) Quality management system Risk analysis (engineering) Biotechnology |
Zdroj: | Journal of Industrial Microbiology & Biotechnology |
ISSN: | 1476-5535 1367-5435 |
Popis: | 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. |
Databáze: | OpenAIRE |
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