title: Scientific rationale behind the development and approval of biosimilar infliximab (CT-P13) in Europe.
abstract: 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.
authors.affiliation: a 1 Justus-Liebig University Gießen, Kerckhoff-Klinik GmbH, Benekestr. 2-8, 61231, Bad Nauheim, Germany.
authors.forename: Ulf
authors.initials: U
authors.lastname: Müller-Ladner
authors.affiliation: b 2 Celltrion, Incheon, Republic of Korea.
authors.forename: SeungSuh
authors.initials: S
authors.lastname: Hong
authors.affiliation: b 2 Celltrion, Incheon, Republic of Korea.
authors.forename: Choongseob
authors.initials: C
authors.lastname: Oh
authors.affiliation: c 3 Kennedy Institute of Rheumatology, University of Oxford, Oxford, UK.
authors.forename: Peter
authors.initials: P
authors.lastname: Taylor
mesh_terms: D000911:Antibodies, Monoclonal / Q000493:pharmacokinetics / Q000627:therapeutic use*; D018501:Antirheumatic Agents / Q000493:pharmacokinetics / Q000627:therapeutic use*; D001172:Arthritis, Rheumatoid / Q000188:drug therapy / Q000378:metabolism; D059451:Biosimilar Pharmaceuticals / Q000493:pharmacokinetics / Q000627:therapeutic use*; D017277:Drug Approval; D005060:Europe; D006801:Humans; D000069285:Infliximab / Q000493:pharmacokinetics / Q000627:therapeutic use; D017063:Outcome Assessment, Health Care; D013167:Spondylitis, Ankylosing / Q000188:drug therapy / Q000378:metabolism
chemical_list: D000911:Antibodies, Monoclonal; D018501:Antirheumatic Agents; D059451:Biosimilar Pharmaceuticals; C000591237:CT-P13; D000069285:Infliximab
keywords: CT-P13; biosimilar; infliximab; manufacture; switchability