Current perspectives on biosimilars |
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Authors: | 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 |
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Institution: | 1.Cytovance Biologics, 800 Research Parkway, Suite 200, Oklahoma City, OK, 73104, USA ;2.BioProcess Technology Group, BDO-USA Life Sciences Practice, 12 Gill St, Suite 5450, Woburn, MA, 01801, USA ;4.Project Farma, 810 W Randolph St, Chicago, IL, 60607, USA ;5.Eppendorf Bioprocess Center, Rudolf-Schulten-Str. 5, 52428, Juelich, Germany ;6.616 Lagrange St, West Lafayette, IN, 47906, USA ;7.Eppendorf Inc, 175 Freshwater Boulevard, Enfield, CT, 06082-4444, USA ;8.Pfenex Inc, 10790 Roselle St, San Diego, CA, 92121, USA ; |
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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. |
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