Mean results for the primary endpoint, ACR20, from the five originator studies conducted in patients with active rheumatoid arthritis who failed previous disease-modifying anti-rheumatic drug (DMARD) therapy comparing anti-TNFα’s in combination with methotrexate versus methotrexate alone
Open Exploration maintains a neutral stance on jurisdictional claims in published institutional affiliations and maps. All opinions expressed in this article are the personal views of the author(s) and do not represent the stance of the editorial team or the publisher.
References
Nick C. Streamlining biosimilar development based on 20 years’ experience.Expert Opin Biol Ther. 2024;24:571–81. [DOI] [PubMed]
Schneider CK, Vleminckx C, Gravanis I, Ehmann F, Trouvin JH, Weise M, et. al. Setting the stage for biosimilar monoclonal antibodies.Nat Biotechnol. 2012;30:1179–85. [DOI] [PubMed]
Kim S, Song J, Park S, Ham S, Paek K, Kang M, et al. Drifts in ADCC-related quality attributes of Herceptin®: Impact on development of a trastuzumab biosimilar.MAbs. 2017;9:704–14. [DOI] [PubMed] [PMC]
Schiestl M, Stangler T, Torella C, Cepeljnik T, Toll H, Grau R. Acceptable changes in quality attributes of glycosylated biopharmaceuticals.Nat Biotechnol. 2011;29:310–2. [DOI] [PubMed]
Kozlowski S, Swann P. Current and future issues in the manufacturing and development of monoclonal antibodies.Adv Drug Deliv Rev. 2006;58:707–22. [DOI] [PubMed]
Liu H, Ponniah G, Zhang HM, Nowak C, Neill A, Gonzalez-Lopez N, et al. In vitro and in vivo modifications of recombinant and human IgG antibodies.MAbs. 2014;6:1145–54. [DOI] [PubMed] [PMC]
Edwards E, Livanos M, Krueger A, Dell A, Haslam SM, Mark Smales C, et al. Strategies to control therapeutic antibody glycosylation during bioprocessing: Synthesis and separation.Biotechnol Bioeng. 2022;119:1343–58. [DOI] [PubMed] [PMC]
Schuster J, Koulov A, Mahler HC, Detampel P, Huwyler J, Singh S, et al. In Vivo Stability of Therapeutic Proteins.Pharm Res. 2020;37:23. [DOI] [PubMed]
Hermeling S, Crommelin DJ, Schellekens H, Jiskoot W. Structure-immunogenicity relationships of therapeutic proteins.Pharm Res. 2004;21:897–903. [DOI] [PubMed]
Rosenberg A, Worobec A. A risk-based approach to immunogenicity concerns of therapeutic protein products, part 2: Considering host-specific and product-specific factors impacting immunogenicity.Biopharm Int. 2004;17:34–42.
Rosenberg AS, Worobec A. A risk-based approach to immunogenicity concerns of therapeutic protein products, part 3: effects of manufacturing changes in immunogenicity and the utility of animal immunogenicity studies.Biopharm Int. 2005;18:22–6.
Eon-Duval A, Broly H, Gleixner R. Quality attributes of recombinant therapeutic proteins: an assessment of impact on safety and efficacy as part of a quality by design development approach.Biotechnol Prog. 2012;28:608–22. [DOI] [PubMed]
Billmeier U, Dieterich W, Neurath MF, Atreya R. Molecular mechanism of action of anti-tumor necrosis factor antibodies in inflammatory bowel diseases.World J Gastroenterol. 2016;22:9300–13. [DOI] [PubMed] [PMC]
Koelink PJ, Bloemendaal FM, Li B, Westera L, Vogels EWM, van Roest M, et al. Anti-TNF therapy in IBD exerts its therapeutic effect through macrophage IL-10 signalling.Gut. 2020;69:1053–63. [DOI] [PubMed] [PMC]
Sipos O, Török A, Kalic T, Duda E, Filkor K. Reverse Signaling Contributes to Control of Chronic Inflammation by anti-TNFα Therapeutics.Antibodies. 2015;4:123–40. [DOI]
Immunogenicity Testing of Therapeutic Protein Products — Developing and Validating Assays for Anti-Drug Antibody Detection Guidance for Industry [Internet].U.S. Food and Drug Administration; c2019 [cited 2024 Nov 15]. Available from: https://www.fda.gov/media/119788/download
Song S, Yang L, Trepicchio WL, Wyant T. Understanding the Supersensitive Anti-Drug Antibody Assay: Unexpected High Anti-Drug Antibody Incidence and Its Clinical Relevance.J Immunol Res. 2016;2016:3072586. [DOI] [PubMed] [PMC]
Doshi S, Wang H, Chow V. Establishing PK Equivalence Between Adalimumab and ABP 501 in the Presence of Antidrug Antibodies Using Population PK Modeling.Clin Ther. 2022;44:111–22. [DOI] [PubMed]
Almoallim H, Al Saleh J, Badsha H, Ahmed HM, Habjoka S, Menassa JA, et al. A Review of the Prevalence and Unmet Needs in the Management of Rheumatoid Arthritis in Africa and the Middle East.Rheumatol Ther. 2021;8:1–16. [DOI] [PubMed] [PMC]
Parisi R, Iskandar IYK, Kontopantelis E, Augustin M, Griffiths CEM, Ashcroft DM; Global Psoriasis Atlas. National, regional, and worldwide epidemiology of psoriasis: systematic analysis and modelling study.BMJ. 2020;369:m1590. [DOI] [PubMed] [PMC]
Kirsch-Stefan N, Guillen E, Ekman N, Barry S, Knippel V, Killalea S, et al. Do the Outcomes of Clinical Efficacy Trials Matter in Regulatory Decision-Making for Biosimilars?BioDrugs. 2023;37:855–71. [DOI] [PubMed] [PMC]
Bielsky MC, Cook A, Wallington A, Exley A, Kauser S, Hay JL, et al. Streamlined approval of biosimilars: moving on from the confirmatory efficacy trial.Drug Discov Today. 2020;[Epub ahead of print]. [DOI] [PubMed]
Jørgensen KK, Olsen IC, Goll GL, Lorentzen M, Bolstad N, Haavardsholm EA, et al.; NOR-SWITCH study group. Switching from originator infliximab to biosimilar CT-P13 compared with maintained treatment with originator infliximab (NOR-SWITCH): a 52-week, randomised, double-blind, non-inferiority trial.Lancet. 2017;389:2304–16. [DOI] [PubMed]
Ye BD, Pesegova M, Alexeeva O, Osipenko M, Lahat A, Dorofeyev A, et al. Efficacy and safety of biosimilar CT-P13 compared with originator infliximab in patients with active Crohn’s disease: an international, randomised, double-blind, phase 3 non-inferiority study.Lancet. 2019;393:1699–707. [DOI] [PubMed]
The Extent of Population Exposureto Assess Clinical Safety for Drugs Intended for Long-Term Treatment of Non-Life-Threatening Conditions E1 [Internet].ICH; c1994 [cited 2024 Nov 15]. Available from: https://database.ich.org/sites/default/files/E1_Guideline.pdf
Herndon TM, Ausin C, Brahme NN, Schrieber SJ, Luo M, Andrada FC, et al. Safety outcomes when switching between biosimilars and reference biologics: A systematic review and meta-analysis.PLoS One. 2023;18:e0292231. [DOI] [PubMed] [PMC]
IPRP Biosimilars Working Group Workshop: “Increasing the Efficiency of Biosimilar Development Programs-Re-evaluating the Need for Comparative Clinical Efficacy Studies (CES)” [Internet].U.S. Food and Drug Administration; [cited 2024 Nov 15]. Available from: https://www.fda.gov/media/172197/download
