Related Experiment Video
Updated: Apr 3, 2026

In Vivo Augmentation of Gut-Homing Regulatory T Cell Induction
Published on: January 22, 2020
Biosimilar infliximab for inflammatory bowel disease: from concepts to clinical practice. Case study illustrated with
Stefan Schreiber1, Julian Panés2, ByoungOh Kwon3
1a 1 Klinik für Innere Medizin I, Universitätsklinikum Schleswig-Holstein, Campus Kiel, Germany.
Abstract:
The introduction of biologic drugs represents the most significant advance in the management of immune-mediated inflammatory diseases for a decade. However, complex proteins are expensive to produce and manufacture. Biosimilar versions of established biologics are becoming available as another version of the reference medicinal product and are expected to provide substantial cost savings. However, because of their complexity, the approval of biosimilars requires strict controls to ensure that all therapeutically relevant characteristics are comparable to the reference medicinal product. This review summarizes the scientific principles and data requirements underpinning regulatory approval of biosimilars and the assumptions that enable extrapolation of data between indications. These important concepts are exemplified by CT-P13 (Remsima(®), Inflectra(®)), the first biosimilar monoclonal antibody approved in Europe.
More Related Videos
11:09An HS-MRM Assay for the Quantification of Host-cell Proteins in Protein Biopharmaceuticals by Liquid Chromatography Ion Mobility QTOF Mass Spectrometry
Published on: April 17, 2018
07:38Multimodal Quantitative Phase Imaging with Digital Holographic Microscopy Accurately Assesses Intestinal Inflammation and Epithelial Wound Healing
Published on: September 13, 2016
Related Concept Videos
Drugs for Treatment of Crohn's Disease in IBD Using Biologic Agents: Anti-TNF
Drugs for Treatment of Crohn's Disease in IBD Using Immunomodulatory Agents
Inflammatory Bowel Disease IV: Pharmacological Management
Pharmacologic...
Drugs for Treatment of Crohn's Disease in IBD Using Glucocorticoids
Drug Products: Biologics, Biosimilars and Interchangeables
Drugs for Treatment of Ulcerative Colitis in IBD