Innovative approaches to biologic development on the trail of CT-P13: biosimilars, value-added medicines, and biobetters
HoUng Kim,
Rieke Alten,
Fraser Cummings,
Silvio Danese,
Geert D’Haens,
Paul Emery,
Subrata Ghosh,
Cyrielle Gilletta de Saint Joseph,
JongHyuk Lee,
James O. Lindsay,
Elena Nikiphorou,
Ben Parker,
Stefan Schreiber,
Steven Simoens,
Rene Westhovens,
Ji Hoon Jeong,
Laurent Peyrin-Biroulet
Affiliations
HoUng Kim
Celltrion Healthcare, Incheon, Republic of Korea
Rieke Alten
Rheumatology Research Center, Schlosspark-Klinik Charité, University Medicine Berlin, Berlin, Germany
Fraser Cummings
Department of Gastroenterology, University Hospital Southampton NHS Foundation Trust, Southampton, UK
Silvio Danese
Humanitas Clinical and Research Center – IRCCS and Department of Biomedical Sciences, Humanitas University, Milan, Italy
Geert D’Haens
Department of Inflammatory Bowel Disease, Amsterdam University Medical Centers, Amsterdam, The Netherlands
Paul Emery
Leeds NIHR Biomedical Research Centre, The Leeds Teaching Hospital Trust, and Leeds Institute of Rheumatic & Musculoskeletal Medicine, University of Leeds, UK
Subrata Ghosh
The Institute of Translational Medicine, Immunology and Immunotherapy, NIHR BRC, University of Birmingham, Birmingham, UK
Cyrielle Gilletta de Saint Joseph
Division of Gastroenterology, Hôpital de Rangueil CHU Toulouse, Toulouse, France
JongHyuk Lee
Department of Pharmaceutical Engineering, College of Life and Health Science, Hoseo University, Asan, Republic of Korea
James O. Lindsay
Department of Gastroenterology, The Royal London Hospital, Barts Health NHS Trust, London, UK
Elena Nikiphorou
Centre for Rheumatic Diseases, King’s College, London, and Rheumatology Department, King’s College Hospital, London, UK
Ben Parker
Kellgren Centre for Rheumatology, Manchester Royal Infirmary, NIHR Manchester Biomedical Research Centre, Manchester, UK
Stefan Schreiber
Department of Medicine I, Christian-Albrechts-University, University Hospital Schleswig-Holstein, Kiel, Germany
Steven Simoens
Department of Pharmaceutical and Pharmacological Sciences, KU Leuven, Leuven, Belgium
Rene Westhovens
Department of Development and Regeneration, Skeletal Biology and Engineering Research Center, Leuven, Belgium
Ji Hoon Jeong
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
Laurent Peyrin-Biroulet
Department of Gastroenterology, Nancy University Hospital, Vandoeuvre-Les-Nancy, France
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.
