Abstracts tagged "biosimilars"

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: 977 • 2018 ACR/ARHP Annual Meeting
Nurse Led Safe Switching from Original Reference Product Infliximab to Biosimalar in Patients with Juvenile Idiopathic Arthritis and Uveitis – a Single Centre Experience Including Baseline and Post Switch Infliximab Levels and Antibodies
Andrew Fell¹, Emma Carson¹, Gillian Coyle¹, Neil Martin¹, Jo Walsh¹ and Janet Gardner-Medwin², ¹Paediatic Rheumatology, Royal hospital for Children, Glasgow, United Kingdom, ²School of Medicine, Dentistry & Nursing, Child Health, University of Glasgow, Glasgow, United Kingdom
Background/Purpose: Original Reference Product (ORP) Infliximab lost market exclusivity in europe in early 2015. The Scottish National Health service (SNHS), runs a national procurement system…
Abstract Number: 1532 • 2018 ACR/ARHP Annual Meeting
Impact of Immunogenicity on Clinical Efficacy and Administration Related Reaction in TNF Inhibitors: A Pooled-Analysis from Three Biosimilar Studies in Patients with Rheumatoid Arthritis
Paul Emery¹, Michael E Weinblatt², Josef S. Smolen³, Edward C. Keystone⁴, Mark C. Genovese⁵, Jiri Vencovsky⁶, Jonathan Kay⁷, Evelyn Hong⁸ and Jeehoon Ghil⁸, ¹University of Leeds and NIHR Leeds Biomedical Research Centre, Leeds, United Kingdom, ²Rheumatology, Immunology and Allergy, Brigham and Women's Hospital, Boston, MA, ³Division of Rheumatology, Department of Medicine 3, Medical University of Vienna, Vienna, Austria, ⁴Mount Sinai Hospital, Toronto, ON, Canada, ⁵Stanford University Medical Center, Palo Alto, CA, ⁶Institute of Rheumatology and Department of Rheumatology, 1st Faculty of Medicine, Charles University, Czech Republic, Prague 2, Czech Republic, ⁷UMass Memorial Medical Center and University of Massachusetts Medical School, Worcester, MA, ⁸Samsung Bioepis Co., Ltd., Incheon, Korea, Republic of (South)
Background/Purpose: SB4, SB2, and SB5 are biosimilars of reference etanercept, infliximab, and adalimumab, respectively. The phase III randomized, double-blind clinical studies comparing the efficacy and…
Abstract Number: 1769 • 2018 ACR/ARHP Annual Meeting
Efficacy and Safety of Biomimic Rituximab in Granulomatosis with Polyangiitis – Experience from a Single Tertiary Care Centre in India
Aman Sharma¹, Sakshi Mittal², GSRSNK Naidu³, Saket Jha², Manish Rathi⁴, Vikas Sharma², Arghya Chattopadhyay⁵, Varun Dhir⁶, Kusum Sharma⁷, Ranjana Minz⁸, Ritambhra Nada⁹ and Sanjay Jain¹⁰, ¹Clinical Immunology and Rheumatology Services, Department of Internal Medicine, Postgraduate Institute of Medical Education and Research, Chandigarh, India, Chandigarh, India, ²Internal Medicine, PGIMER, Chandigarh, India, ³PGIMER, cHANDIGARH, India, ⁴Department of Nephrology,, Postgraduate Institute of Medical Education and Research, Chandigarh, India, ⁵PGIMER, Chandigarh, India, ⁶Internal Medicine (Rheumatology Unit), Postgraduate Institute of Medical Education and Research, Chandigarh, India, Chandigarh, India, ⁷Department of Medical Microbiology,, PGIMER,, Chandigarh, India, ⁸Department of Immunopathology,, PGIMER,, Chandigarh, India, ⁹Postgraduate Institute of Medical Education and Research, Chandigarh, India, ¹⁰Postgraduate Institute of Medical Education and Research, Chandigarh, India, CHANDIGARH, India
Background/Purpose: Though rituximab(RTX) has become a standard of care for remission induction and maintenance in Granulomatosis with Polyangiitis(GPA), there is very limited data on the…
Abstract Number: 1936 • 2018 ACR/ARHP Annual Meeting
A Randomized, Double-Blind, Parallel-Group, Multicenter Study to Compare the Efficacy, Safety and Immunogenicity of a Proposed Adalimumab Biosimilar (GP2017) with Reference Adalimumab in Patients with Moderate-to-Severe Active Rheumatoid Arthritis
Piotr Wiland¹, Sławomir Jeka², Eva Dokoupilová^3,4, Juan Manuel Miranda Limón⁵, Julia Jauch-Lembach⁶, Anjali Thakur⁶, Halimuniyazi Haliduola⁶ and Norman B Gaylis⁷, ¹Wrocław Medical University, Wrocław, Poland, ²Collegium Medicum UMK, 2nd University Hospital, Bydgoszcz, Poland, ³MEDICAL PLUS s.r.o., Uherské Hradiště, Czech Republic, ⁴Faculty of Pharmacy, University of Veterinary and Pharmaceutical sciences, Brno, Czech Republic, ⁵RM Pharma Specialists, Mexico City, Mexico, ⁶Hexal AG, Holzkirchen, Germany, ⁷Arthritis & Rheumatic Disease Specialties, Aventura, FL
Background/Purpose: GP2017, a proposed adalimumab biosimilar, matched reference adalimumab (refADL) in preclinical and pharmacokinetics studies.1,2 The confirmatory efficacy and safety study in patients with plaque-type…
Abstract Number: 2154 • 2018 ACR/ARHP Annual Meeting
Biosimilar Infliximab Treated-Patients with Rheumatoid Arthritis, Psoriatic Arthritis, and Ankylosing Spondylitis in France: Characteristics and Clinical Outcomes
Hubert Marotte¹, NADIR MAMMAR² and Bruno Fautrel³, ¹University Hospital of Saint Etienne,, Saint Etienne, France, ²Pfizer, PARIS, France, ³Institut Pierre Louis d'Epidémiologie et de Santé Publique (iPLESP), UMR S 1136, Sorbonne Université, GRC-UPMC 08, Paris, France
Background/Purpose: CT-P13 was the first monoclonal antibody biosimilar to infliximab (IFX) approved in France. Reflect trial has been set up to evaluate in real life…
Abstract Number: 2367 • 2018 ACR/ARHP Annual Meeting
Acceptance Rate and Sociological Factors Involved in the Switch from Originator to Biosimilar Etanercept (SB4)
Marc Scherlinger^1,2,3, Vincent Germain¹, Emmanuel Langlois⁴ and Thierry Schaeverbeke⁵, ¹Department of Rheumatology, Bordeaux University Hospital, Bordeaux, France, ²FHU ACRONIM, Bordeaux, France, ³Rheumatology, UMR CNRS 5164 - Immunoconcept, France, Bordeaux, France, ⁴CNRS-UMR 5116 Centre Emile Durkheim, Bordeaux, France, ⁵Department of Rheumatology, Bordeaux University Hospital, BORDEAUX, France
Background/Purpose: Biosimilars represent major potential savings while preserving treatment quality. However, few data are known on how to address the switch from originator to biosimilar…
Abstract Number: 2384 • 2018 ACR/ARHP Annual Meeting
Biosimilar Use in Young Adults with Juvenile Idiopathic Arthritis in Germany
Jens Klotsche¹, Martina Niewerth¹, Gerd Horneff² and Kirsten Minden^3,4, ¹Program Area Epidemiology, German Rheumatism Research Center, Berlin, Germany, ²Department of Pediatrics, Asklepios Clinics St. Augustin, Sankt Augustin, Germany, ³Charité–Universitätsmedizin Berlin, Berlin, Germany, ⁴German Rheumatism Research Center, Berlin, Germany
Background/Purpose: The first biosimilars have been approved for the treatment of juvenile idiopathic arthritis (JIA) in the last two years. To date, only a few…
Abstract Number: 2515 • 2018 ACR/ARHP Annual Meeting
Joint Damage Progression According to Disease Activity States in Patients with Rheumatoid Arthritis Treated with CT-P10 and Reference Rituximab: Up to 48 Weeks Results from Phase III Study
Chang-Hee Suh¹, Dae-Hyun Yoo², Won Park³, Seung-Cheol Shim⁴, Sang-Joon Lee⁵, Yun Ju Bae⁵, Sang Eun Han⁵ and Sang Mi Lee⁵, ¹Rheumatology, Ajou University School of Medicine, Suwon, Korea, Republic of (South), ²Department of Rheumatology, Hanyang University Hospital for Rheumatic Diseases, Seoul, Korea, Republic of (South), ³Medicine/Rheumatology, Inha University Hospital, Incheon, Korea, Republic of (South), ⁴Division of Rheumatology, Department of Internal Medicine, Daejeon Rheumatoid & Degenerative Arthritis Center, Chungnam National University Hospital, Daejeon, Korea, Republic of (South), ⁵CELLTRION, Inc., Incheon, Korea, Republic of (South)
Background/Purpose: CT-P10 is a biosimilar of the reference rituximab (RTX) and has been approved by several regulatory agencies including EMA. Pharmacokinetic and therapeutic equivalence from…
Abstract Number: 2521 • 2018 ACR/ARHP Annual Meeting
A Randomized, Double-Blind Phase III Study Comparing the Efficacy, Safety and Immunogenicity of PF-06438179/GP1111 (Ixifi™), an Infliximab Biosimilar, and Infliximab Reference Product (Remicade®) in Patients with Moderate to Severe Active RA: Results from Week 54 to Week 78
Stanley Cohen¹, Alan J. Kivitz², Michael Tee³, Carol Cronenberger⁴, Min Zhang⁵, Sarah Hackley⁶, Karl Schumacher⁷ and Muhammad I. Rehman⁸, ¹Metroplex Clinical Research Center, LLC, Dallas, TX, ²Altoona Center for Clinical Research, Duncansville, PA, ³Department of Medicine, Medical Center Manila and University of the Philippines, Manila, Philippines, ⁴Pfizer Inc, Collegeville, PA, ⁵Pfizer Inc, La Jolla, CA, ⁶Pfizer Ltd, Sandwich, United Kingdom, ⁷Global Clinical Development, Biopharmaceuticals, Sandoz Biopharmaceuticals, Holzkirchen, Germany, ⁸Pfizer Inc, Andover, MA
Background/Purpose: PF-06438179/GP1111 (IFX-PF) is an infliximab (IFX) biosimilar for the treatment of immune-mediated inflammatory diseases, including RA. This randomized, double-blind, comparative clinical study evaluated the…
Abstract Number: 2522 • 2018 ACR/ARHP Annual Meeting
Biosimilar BI 695501 and Adalimumab Reference Product (RP) Have Similar Efficacy and Safety in Patients (pts) with Moderately-to-Severely Active Rheumatoid Arthritis (RA): Long-Term Results from a Phase IIIb Extension Study (VOLTAIRE®-RAext)
Stanley Cohen¹, Niklas Czeloth², Eric Lee³, Piotr A. Klimiuk⁴, Nuala Peter⁵ and Girish Jayadeva², ¹Metroplex Clinical Research Center, Dallas, TX, ²Boehringer Ingelheim, Ingelheim a.R., Germany, Ingelheim, Germany, ³Inland Rheumatology, Upland, CA, ⁴Medical University of Bialystok and Gabinet Internistyczno-Reumatologiczny, Bialystok, Poland, ⁵Boehringer Ingelheim, Biberach a.d.R., Germany, Ingelheim a.R., Germany
Background/Purpose: Clinical equivalence of BI 695501 to the adalimumab RP has been shown in pts with moderately-to-severely active RA in the Phase III VOLTAIRE®-RA study…
Abstract Number: 2526 • 2018 ACR/ARHP Annual Meeting
Revealing and Addressing Knowledge Gaps Regarding Biosimilars in Rheumatology Practice with Targeted Continuing Education and Patient Surveys
Katie Robinson and Robert Esgro, Vindico Medical Education, Thorofare, NJ
Background/Purpose: With the recent introduction of biosimilars in the US market, providers lack knowledge of how these agents compare to reference biologics and the implications…

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