Figure 1 Biosimilar development process

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Presentation transcript:

Figure 1 Biosimilar development process Figure 1 | Biosimilar development process. The development of biosimilars is challenging, as there is no access to originator data. It requires selection of an appropriate reference biologic agent, understanding of the key molecular attributes of the reference product, development of a manufacturing process to match these attributes, and finally preclinical and clinical evaluation. PK/PD, pharmacokinetic/pharmacodynamic studies; RCTs, randomized controlled trials. Danese, S. et al. (2016) Biosimilars in IBD: from theory to practice Nat. Rev. Gastroenterol. Hepatol. doi:10.1038/nrgastro.2016.155