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Biosimilars 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.

Original publication

DOI

10.1586/1744666X.2015.1090310

Type

Journal article

Journal

Expert Rev Clin Immunol.

Publication Date

22/09/2015

Volume

11

Pages

5 - 14