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Review
. 2019 Oct;46(9-10):1297-1311.
doi: 10.1007/s10295-019-02216-z. Epub 2019 Jul 17.

Current perspectives on biosimilars

Frank K Agbogbo  1 , Dawn M Ecker  2 , Allison Farrand  3 , Kevin Han  4   5 , Antoine Khoury  6 , Aaron Martin  3 , Jesse McCool  3 , Ulrike Rasche  7 , Tiffany D Rau  8 , David Schmidt  3 , Ma Sha  5 , Nicholas Treuheit  9
Affiliations
Review

Current perspectives on biosimilars

Frank K Agbogbo et al. J Ind Microbiol Biotechnol. 2019 Oct.

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.

Keywords: Analytical; Biosimilars; Mammalian; Manufacturing; Microbial; Quality.

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Figures

Fig. 1
Fig. 1
Originators versus biosimilars—development path [19]
Fig. 2
Fig. 2
Current Biopharmaceutical Pipeline Distributed by Phase* and Production Technology. *Market refers to all US and EU Approved for Market Products, not all of which may be commercially available. The term microbial or mammalian refers to the type of host organism used to produce the biosimilar drug. BLA biologic license application, MAA marketing authorization application, NDA new drug application
Fig. 3
Fig. 3
Current Biosimilar Pipeline Distributed by Phase* and Production Technology. *Market refers to all US and EU Approved for Market Products, not all of which may be commercially available. Percentages shown represent biosimilar share of biopharmaceuticals in a given Phase. Biosimilar products progress from Phase 1 directly to Phase 3. The term microbial or mammalian refers to the type of host organism used to produce the biosimilar drug. BLA biologic license application, MAA marketing authorization application, NDA new drug application
Fig. 4
Fig. 4
Mammalian-based biosimilar targets. The term Mammalian refers to the type of host organism used to produce the biosimilar drug. BLA biologic license application, MAA marketing authorization application
Fig. 5
Fig. 5
Biosimilar targets for microbial-based biopharmaceuticals. The term microbial refers to the type of host organism used to produce the biosimilar drug. BLA biologic license application, MAA marketing authorization application, NDA new drug application
Fig. 6
Fig. 6
The canonical diagram for drug development for biosimilars compared to originator biologics
Fig. 7
Fig. 7
Cell growth profiles in a batch process. Viable cell densities were determined in cultures in the BioBLU 0.3c (0.25 L) Single-Use Vessel, the BioBLU 3c (3.75 L) Single-Use Vessel, and the BioBLU 50c (40 L) Single-Use Vessel. There were no replicates for these runs
Fig. 8
Fig. 8
Antibody production in a batch process. mAb concentrations were determined in cultures in the BioBLU 0.3c (0.25 L) Single-Use Vessel, the BioBLU 3c (3.75 L) Single-Use Vessel, and the BioBLU 50c (40 L) Single-Use Vessel. There were no replicates for these runs
Fig. 9
Fig. 9
The process steps that could be involved in the manufacture of a biosimilar
See this image and copyright information in PMC

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