By Frank K. Agbogbo1, Dawn M. Ecker2, Allison Farrand1, Kevin Han3,7, Antoine Khoury4, Aaron Martin1, Jesse McCool1, Ulrike Rasche5, Tiffany D. Rau6, David Schmidt1, Ma Sha7, Nicholas Treuheit8
Originally published by Journal of Industrial Microbiology & Biotechnology (2019) 46:1297–1311
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.