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Abstracts tagged "biosimilars"

  • Abstract Number: 0745 • ACR Convergence 2021

    Patient-reported Outcomes and Safety Measures in Patients with Rheumatic Diseases Who Switched from Reference or Other Biosimilar Etanercept to Biosimilar Etanercept GP2015 and in Biologic-naïve Patients Starting a Treatment with GP2015: 12-month Interim Analysis from a Real-world Study

    Ayman Askari1, Marc Schmalzing2, Slawomir Jeka3, Javier De Toro Santos4, Eduardo Collantes-Estevez5, Fabricio Furlan6, Sohaib Hachaichi6 and Herbert Kellner7, 1The Robert Jones and Agnes Hunt Orthopaedic Hospital, Shropshire, United Kingdom, 2Rheumatology/Clinical Immunology, Department of Internal Medicine II, University of Wuerzburg, Wuerzburg, Germany, 3Clinic and Department of Rheumatology and Connective Tissue Diseases, University Hospital No 2 in Bydgoszcz Collegium Medicum UMK in Toruń, Bydgoszcz, Poland, 4University Hospital Coruña, Servicio de Reumatología, A Coruña, Galicia, Spain, 5IMIBIC/Reina Sofia Hospital/University of Córdoba, Córdoba, Spain, 6Hexal AG (A Sandoz company), Holzkirchen, Germany, Holzkirchen, Germany, 7Hospital Neuwittelsbach, Center for Rheumatology and Gastroenterology, Munich, Germany, Munich, Germany

    Background/Purpose: GP2015 is a biosimilar of etanercept (ETN). COMPACT is an ongoing, non-interventional study, evaluating the effectiveness, safety, and quality of life with GP2015 treatment…
  • Abstract Number: 0823 • ACR Convergence 2021

    Pharmacokinetic and Pharmacodynamic Evaluation of a Proposed Biosimilar MSB11456 versus Both the US-licensed and EU-approved Tocilizumab: Results of a Randomized, Double-blind, Parallel-group, Single-dose Trial in Healthy Adults

    Christian Schwabe1, Chris Wynne2, Andras Illes3, Martin Ullmann3, Emmanuelle Vincent3, Vishal Ghori3, Corinne Petit-Frere3, Anne-Sophie Racault3 and Joelle Monnet3, 1Auckland Clinical Studies Ltd, Auckland, New Zealand, 2Christchurch Clinical Studies Trust Ltd, Christchurch, New Zealand, 3Fresenius Kabi SwissBioSim, Eysins, Switzerland

    Background/Purpose: Tocilizumab, a biologic disease-modifying antirheumatic drug, is a recombinant humanized monoclonal immunoglobulin G1 antibody against the interleukin-6 receptor (IL-6R). MSB11456 is a proposed biosimilar…
  • Abstract Number: 042 • 2020 Pediatric Rheumatology Symposium

    Safety Analysis of Infliximab-dyyb as Compared to Infliximab in Pediatric Rheumatic Conditions

    Mary Culp 1, Dusty Lewis 1, Bethanne Thomas 2, Fatima Barbar-Smiley 3, Kyla Driest 4, Edward Oberle 4, Stacy Ardoin 1 and Kelly Wise1, 1Nationwide Children's Hospital, Columbus, 2Nationwide Children's, Columbus, 3Nationwide Children's Hospital, Columbus, Ohio, 4Division of Rheumatology, Nationwide Children's Hospital, Columbus

    Background/Purpose: Infliximab is an effective treatment for many pediatric rheumatic conditions, but high medication cost creates a barrier to patient access. Biosimilar drugs are proven…
  • Abstract Number: 050 • 2020 Pediatric Rheumatology Symposium

    Long Term Safety of Biologics and Biosimilars in Pediatric Rheumatic Diseases: An Experience from a Single North Indian Centre

    MANJARI AGARWAL 1, Sujata Sawhney2 and Anju Singh 3, 1Sir Ganga Ram Hospital, NEW DELHI, Delhi, India, 2Sir ganga ram hospital, Sector 37 noida, Uttar Pradesh, India, 3Sir Ganga Ram Hospital, delhi, India

    Background/Purpose:  The use of biologic response modifiers(BRMs) is associated with an increased risk of infections.We also use biosimilars for two reasons:1. originator not available, like…
  • Abstract Number: 549 • 2019 ACR/ARP Annual Meeting

    US Rheumatologists’ Beliefs and Knowledge About Biosimilars – an Ongoing Survey

    Allan Gibofsky1, Dorothy McCabe 2 and Sam Badawi 2, 1Weill Cornell Medical College, New York, NY, 2Boehringer Ingelheim, Ridgefield, CT

    Background/Purpose: A systematic review of survey literature from 2014-2018 found that clinicians in the US and Europe are cautious about biosimilar use (JMCP; 2019;25:102). We…
  • Abstract Number: 1115 • 2019 ACR/ARP Annual Meeting

    Switching Patterns Among Patients with Chronic Inflammatory Diseases Switching to an Infliximab Biosimilar or Remaining on Originator Infliximab (REMICADE)

    Bruno Emond 1, Kay Sadik 2, Marie-Hélène Lafeuille 1, Willy Wynant 1, Aurélie Côté-Sergent 1, Patrick Lefebvre 1, Kimberly Woodruff 2 and Timothy Fitzgerald3, 1Analysis Group, Inc, Montreal, QC, Canada, 2Janssen Scientific Affairs, LLC, Titusville, NJ, 3Janssen Scientific Affairs, LLC, Horsham, PA

    Background/Purpose: Chronic inflammatory diseases (CIDs) such as rheumatoid arthritis (RA), psoriatic arthritis (PsA), plaque psoriasis (PsO), ankylosing spondylitis (AS), Crohn's disease (CD), and ulcerative colitis…
  • Abstract Number: 1116 • 2019 ACR/ARP Annual Meeting

    Non-medical Switching from Reference to Biosimilar Etanercept – No Evidence for Nocebo Effect – a Retrospective Analysis of Real-life Data

    Uta Kiltz1, Styliani Tsiami 1, Xenofon Baraliakos 2 and Jürgen Braun 3, 1Rheumazentrum Ruhrgebiet/Ruhr University Bochum, Herne, Germany, Herne, Germany, 2Rheumazentrum Ruhrgebiet-Ruhr-University Bochum, Herne, Germany, Herne, Germany, 3Rheumazentrum Ruhrgebiet/Ruhr University, Herne, Germany

    Background/Purpose: Real-world data about switching patients from originator product to a biosimilars are important to assess and to document the outcome of switches in clinical…
  • Abstract Number: 1118 • 2019 ACR/ARP Annual Meeting

    US Community Rheumatologists’ Knowledge and Perceptions of Biosimilar Expanded Indication Approval by Extrapolation

    Ting-Chun Yeh1, Yolaine Jeune-Smith 1, Eli Phillips 1, Ajeet Gajra 1 and Bruce Feinberg 1, 1Cardinal Health Specialty Solutions, Dublin, OH

    Background/Purpose: To expand treatment options, increase access to life-saving medications, and lower healthcare costs through competition, the US Congress created an abbreviated licensure pathway for…
  • Abstract Number: 2406 • 2019 ACR/ARP Annual Meeting

    Hepatobiliary Events in >5000 Patients with Inflammatory Arthritis Treated with Biosimilar or Originator Etanercept in Routine Care, Results from the Danish Nationwide DANBIO Registry

    Bente Glintborg 1, Stylianos Georgiadis 2, Mette Nørgaard 3, Frank Mehnert 3, Kathrine Lederballe Grøn 1, Niels Steen Krogh 4 and Merete Lund Hetland1, 1DANBIO and Copenhagen Center for Arthritis Research (COPECARE), Center for Rheumatology and Spine Diseases, Centre of Head and Orthopaedics, Rigshospitalet, Copenhagen, Denmark, 2DANBIO registry and Copenhagen Center for Arthritis Research, Centre for Rheumatology and Spine Diseases, Rigshospitalet, Copenhagen, Denmark, 3Department of Clinical Epidemiology, Aarhus University Hospital, Aarhus, Denmark, 4Zitelab / DANBIO, Copenhagen, Denmark

    Background/Purpose: Marketing of biosimilar biological drugs may significantly reduce drug costs if comparable safety and efficacy of originator and the biosimilar can be documented. In…
  • Abstract Number: 205 • 2019 ACR/ARP Annual Meeting

    Does a Mandatory Non-medical Switch from Originator to Biosimilar Etanercept Lead to Increase in Healthcare Use and Costs? A Danish Register-based Study of 1620 Patients with Inflammatory Arthritis

    Bente Glintborg 1, Rikke Ibsen 2, Rebekka Elisabeth Qwist Bilbo 3, Merete Lund Hetland1 and Jakob Kjellberg 3, 1DANBIO and Copenhagen Center for Arthritis Research (COPECARE), Center for Rheumatology and Spine Diseases, Centre of Head and Orthopaedics, Rigshospitalet, Copenhagen, Denmark, 2i2minds, Aarhus, Denmark, 3VIVE, The Danish Centre for Social Science Research, Copenhagen, Denmark

    Background/Purpose: Marketing of cheaper biosimilar biological agents has created financial incentives for switching from the corresponding originator drugs (=non-medical switch). The economic benefit might potentially…
  • Abstract Number: 207 • 2019 ACR/ARP Annual Meeting

    Effects of Successive Switches to Different Biosimilars Infliximab on Immunogenicity in Chronic Inflammatory Diseases in Daily Clinical Practice

    Ambre Lauret 1, Anna Moltó 1, Vered Abitbol 2, Loriane Guterlann 3, Ornella Conort 3, Francois Chast 3, Claire Goulvestre 4, Claire Le Jeunne 5, Stanislas Chaussade 2, Christian Roux 1, Frédéric Batteux 6, Maxime Dougados 7, Yannick Allanore 1 and Jerome Avouac1, 1Paris Descartes University, Cochin Hospital, Rheumatology department, Paris, France, 2Paris Descartes University, Cochin Hospital, Gastroenterology department, Paris, France, 3Paris Descartes University, Cochin Hospital, Department of Pharmacy, paris, France, 4Paris Descartes University, Cochin Hospital, Immunology Laboratory, Paris, France, 5Paris Descartes University, Cochin Hospital, Internal Medicine department, Paris, France, 6Paris Descartes University, Cochin Hospital, Immunology Laborator, Paris, France, 7Cochin Hospital, Paris, France

    Background/Purpose: To determine whether the successive switches from innovator infliximab to a first then a second biosimilar infliximab, or from a first to a second…
  • Abstract Number: 251 • 2019 ACR/ARP Annual Meeting

    Long-term Financial Impact of Switching from Reference to Biosimilar Etanercept When Considering Short-term Formulary Management Costs in the US

    Dylan Mezzio 1, Edward Li2 and Sanjeev Balu 3, 1Xcenda, Pleasant Hill, CA, 2Sandoz Inc., Princeton, NJ, 3Sandoz Inc, Princeton, NJ

    Background/Purpose: Biosimilars have enabled some US institutions and payers to achieve significant financial savings after implementing a formulary change from the reference biologic. However, within…
  • Abstract Number: 310 • 2019 ACR/ARP Annual Meeting

    Efficacy, Immunogenicity and Cost Analysis of a Systematic Switch from Originator Infliximab to Biossimilar CT-P13 of All Patients with Inflamatory Arthritis from a Single Center

    Ana Valido1, Joana Silva-Dinis 2, Maria João Saavedra 1, Inês Iria 3, João Gonçalves 3, João Cruz 4, Nuno Bernardo 5 and João Eurico Fonseca 2, 1Serviço de Reumatologia e Doenças Ósseas Metabólicas, Hospital de Santa Maria, CHLN; Lisboa, Portugal., Lisbon, Portugal, 2Rheumatology and Bone Diseases Department, Hospital de Santa Maria, Centro Hospitalar Universitário Lisboa Norte; Unidade de Investigação em Reumatologia, Instituto de Medicina Molecular, Faculdade de Medicina, Universidade de Lisboa; Centro Académico de Medicina de Lisboa; Lisbon, Portugal., Lisbon, Portugal, 3Faculdade de Farmácia da Universidade de Lisboa; Portugal, Lisbon, Portugal, 4Associate Professor with Habilitation, Faculdade de Farmácia da Universidade de Lisboa, Portugal, Lisbon, Portugal, 5Unidade de Negociação – Serviço de Gestão de Compras, Hospital Santa Maria, CHLN, Lisboa, Portugal., Lisbon, Portugal

    Background/Purpose: Biotechnological drugs are a fundamental resource for the treatment (Tx) of rheumatic patients (Pts). Biosimilar drugs are intended to be as effective as the…
  • Abstract Number: 514 • 2019 ACR/ARP Annual Meeting

    A Pooled Analysis of 1-year Clinical Outcomes Among 6-month Responders and Non-responders from Three Randomized Controlled Studies of TNF Inhibitor Biosimilars in Patients with Rheumatoid Arthritis

    Josef Smolen1, Michael Weinblatt 2, Paul Emery 3, Jung Yoon Choe 4, Jonathan Kay 5, Jieun Lee 6, Gihyun Myung 6, Hyoryeong Seo 6 and Jeehoon Ghil 6, 1Medical University of Vienna, Vienna, Austria, 2Brigham and Women's Hospital, Boston, MA, 3Leeds Institute of Rheumatic and Musculoskeletal Medicine, Leeds, United Kingdom, 4Division of Rheumatology, Daegu Catholic University Medical Center, Daegu, Republic of Korea, 5UMass Memorial Medical Center and University of Massachusetts Medical School, Worcester, MA, 6Samsung Bioepis Co., Ltd., Incheon, Republic of Korea

    Background/Purpose: SB4, SB2, and SB5 are biosimilars of etanercept, infliximab, and adalimumab. Phase III randomized, double-blind studies were conducted to compare efficacy and safety between…
  • Abstract Number: 519 • 2019 ACR/ARP Annual Meeting

    Efficacy of Biosimilar Candidate ABP 710 in a Phase 3 Study in Subjects with Moderate to Severe RA: Additional Analysis Focusing on the ACR Individual Components

    Mark Genovese1, Juan Sanchez-Burson 2, Éva Balázs 3, Andrea Everding 4, MyungShin Oh 5, Gary Fanjiang 5 and Stanley Cohen 6, 1Stanford University, Stanford, CA, 2Hospital Infanta Luisa, Sevilla, Spain, 3Dr. Bugyi István Hospital, Szentes, Hungary, 4HRF Hamburger Rheuma Forschungszentrum, Hamburg, Germany, 5Amgen, Thousand Oaks, CA, 6Metroplex Clinical Research Center, Dallas, TX

    Background/Purpose: ABP 710 is being developed as a biosimilar to infliximab. Both ABP 710 and infliximab reference product (RP) inhibit tumor necrosis factor-alpha. Following demonstration…
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Embargo Policy

All abstracts accepted to ACR Convergence are under media embargo once the ACR has notified presenters of their abstract’s acceptance. They may be presented at other meetings or published as manuscripts after this time but should not be discussed in non-scholarly venues or outlets. The following embargo policies are strictly enforced by the ACR.

Accepted abstracts are made available to the public online in advance of the meeting and are published in a special online supplement of our scientific journal, Arthritis & Rheumatology. Information contained in those abstracts may not be released until the abstracts appear online. In an exception to the media embargo, academic institutions, private organizations, and companies with products whose value may be influenced by information contained in an abstract may issue a press release to coincide with the availability of an ACR abstract on the ACR website. However, the ACR continues to require that information that goes beyond that contained in the abstract (e.g., discussion of the abstract done as part of editorial news coverage) is under media embargo until 10:00 AM CT on October 25. Journalists with access to embargoed information cannot release articles or editorial news coverage before this time. Editorial news coverage is considered original articles/videos developed by employed journalists to report facts, commentary, and subject matter expert quotes in a narrative form using a variety of sources (e.g., research, announcements, press releases, events, etc.).

Violation of this policy may result in the abstract being withdrawn from the meeting and other measures deemed appropriate. Authors are responsible for notifying colleagues, institutions, communications firms, and all other stakeholders related to the development or promotion of the abstract about this policy. If you have questions about the ACR abstract embargo policy, please contact ACR abstracts staff at [email protected].

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