Innovative approaches to biologic development on the trail of CT-P13: biosimilars, value-added medicines, and biobetters

mAbs

Subrata Ghosh¹  HoUng Kim²  Ben Parker³  Ji Hoon Jeong⁴  Elena Nikiphorou⁵  Fraser Cummings⁶  Laurent Peyrin-Biroulet⁷  Geert D’Haens⁸  Steven Simoens⁹  James O. Lindsay^1,10  Rene Westhovens^1,11  JongHyuk Lee^1,12  Silvio Danese^1,13  Stefan Schreiber^1,14  Paul Emery^1,15  Rieke Alten^1,16  Cyrielle Gilletta de Saint Joseph^1,17 

[1] Musculoskeletal Medicine, University of Leeds, UK;Celltrion Healthcare, Incheon, Republic of Korea;Centre for Rheumatic Diseases, King’s College, London, and Rheumatology Department, King’s College Hospital, London, UK;Department of Development and Regeneration, Skeletal Biology and Engineering Research Center, Leuven, Belgium;Department of Gastroenterology, The Royal London Hospital, Barts Health NHS Trust, London, UK;Department of Gastroenterology, University Hospital Southampton NHS Foundation Trust, Southampton, UK;Department of Global Innovative Drugs, Graduate School of Chung-Ang University and Department of Pharmacology, College of Medicine, Chung-Ang University, Seoul, Republic of Korea;Department of Inflammatory Bowel Disease, Amsterdam University Medical Centers, Amsterdam, The Netherlands;Department of Medicine I, Christian-Albrechts-University, University Hospital Schleswig-Holstein, Kiel, Germany;Department of Pharmaceutical Engineering, College of Life and Health Science, Hoseo University, Asan, Republic of Korea;Department of Pharmaceutical and Pharmacological Sciences, KU Leuven, Leuven, Belgium;Division of Gastroenterology, Hôpital de Rangueil CHU Toulouse, Toulouse, France;Humanitas Clinical and Research Center – IRCCS and Department of Biomedical Sciences, Humanitas University, Milan, Italy;Kellgren Centre for Rheumatology, Manchester Royal Infirmary, NIHR Manchester Biomedical Research Centre, Manchester, UK;;Leeds NIHR Biomedical Research Centre, The Leeds Teaching Hospital Trust, and Leeds Institute of Rheumatic &Rheumatology Research Center, Schlosspark-Klinik Charité, University Medicine Berlin, Berlin, Germany;The Institute of Translational Medicine, Immunology and Immunotherapy, NIHR BRC, University of Birmingham, Birmingham, UK;

关键词: Biobetter;    biologic;    biosimilar;    CT-P13;    infliximab;    innovative biologics;   

DOI  :  10.1080/19420862.2020.1868078

来源: DOAJ

【 摘 要 】

The biosimilar concept is now well established. Clinical data accumulated pre- and post-approval have supported biosimilar uptake, in turn stimulating competition in the biologics market and increasing patient access to biologics. Following technological advances, other innovative biologics, such as “biobetters” or “value-added medicines,” are now reaching the market. These innovative biologics differ from the reference product by offering additional clinical or non-clinical benefits. We discuss these innovative biologics with reference to CT-P13, initially available as an intravenous (IV) biosimilar of reference infliximab. A subcutaneous (SC) formulation, CT-P13 SC, has now been developed. Relative to CT-P13 IV, CT-P13 SC offers clinical benefits in terms of pharmacokinetics, with comparable efficacy, safety, and immunogenicity, as well as increased convenience for patients and reduced demands on healthcare system resources. As was once the case for biosimilars, nomenclature and regulatory pathways for innovative biologics require clarification to support their uptake and ultimately benefit patients.

【 授权许可】

Unknown