• Expert Rev Clin Immunol · Jan 2015

    Review

    Scientific rationale behind the development and approval of biosimilar infliximab (CT-P13) in Europe.

    • Ulf Müller-Ladner, SeungSuh Hong, Choongseob Oh, and Peter Taylor.
    • a 1 Justus-Liebig University Gießen, Kerckhoff-Klinik GmbH, Benekestr. 2-8, 61231, Bad Nauheim, Germany.
    • Expert Rev Clin Immunol. 2015 Jan 1; 11 Suppl 1: S5-14.

    AbstractBiosimilars are drugs developed to be highly similar to their originator biologic (or 'reference medicinal product') with no clinically meaningful differences in purity, efficacy or safety. Production of biologics and biosimilars is highly complex and sensitive, with any change in manufacturing process having a potential impact on efficacy and safety. This review provides an overview of the manufacturing process for these drugs and considers the implications of any process changes. The scientific rationale underlying the regulatory comparability exercise for process-changed reference medicinal products and biosimilars is also discussed, as is the issue of 'switchability' from a reference medicinal product to its biosimilar. CT-P13 (Remsima(®), Inflectra(®)), a biosimilar of infliximab, is used as a case study to discuss these issues.

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