Key considerations in the preclinical development of biosimilars
2015; Elsevier BV; Volume: 20; Linguagem: Inglês
10.1016/j.drudis.2015.03.011
ISSN1878-5832
AutoresLynne A. Bui, Susan Hurst, Gregory L. Finch, Beverly Ingram, Ira Jacobs, Carol F. Kirchhoff, Chee-Keng Ng, Anne Ryan,
Tópico(s)CAR-T cell therapy research
ResumoBiosimilar development requires several steps: selection of an appropriate reference biologic, understanding the key molecular attributes of that reference biologic and development of a manufacturing process to match these attributes of the reference biologic product. The European Medicines Agency (EMA) and the FDA guidance documents state that, in lieu of conducting extensive preclinical and clinical studies typically required for approval of novel biologics, biosimilars must undergo a rigorous similarity evaluation. The aim of this article is to increase understanding of the preclinical development and evaluation process for biosimilars, as required by the regulatory agencies, that precedes the clinical testing of biosimilars in humans.
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