Abstracts tagged "biosimilars"

Abstract Number: 2644 • 2016 ACR/ARHP Annual Meeting
Patient Survey Regarding Generic and Bio-Similar Drugs
Tsukasa Matsubara¹, Tamami Yoshitama¹, Kou Katayama¹, Shigehito Kiyokawa², Nobumasa Miyake², Motohiro Oribe², Akira Sagawa² and Keiko Funahashi³, ¹Japanese clinician biologics research group, Kobe, Hyogo, Japan, ²Japanese clinician biologics research group, Kobe, Japan, ³Clinical Research, Matsubara Mayflower Hospital, Kato, Japan
Background/Purpose: In Japan the market share for generic drugs is 50%, lower than that in Western nations. This is partially due to Japan’s insurance system,…
Abstract Number: 603 • 2016 ACR/ARHP Annual Meeting
Additional Efficacy Results of SB4 (Etanercept Biosimilar) up to Week 100: Comparison Between Continuing SB4 and Switching from Reference Etanercept (Enbrel®) to SB4
Paul Emery¹, Jiří Vencovský², Anna Sylwestrzak³, Piotr Leszczyñski⁴, Wieslawa Porawska⁵, Barbara Stasiuk⁶, Joanna Hilt⁷, Zdenka Mosterova⁸, Soo Yeon Cheong⁹ and Jeehoon Ghil⁹, ¹University of Leeds, Midlothian, United Kingdom, ²Institute of Rheumatology, Department of Rheumatology, 1st Faculty of Medicine, Charles University, Prague, Czech Republic, ³NZOZ Medica Pro Familia Sp. z o.o., Warsaw, Poland, ⁴Rheumatology and Rehabilitation, Poznan University of Medical Sciences, Poznan, Poland, ⁵Poznanski Osrodek Medyczny NOVAMED, Poznan, Poland, ⁶Medicome Sp. z o.o., Oswiecim, Poland, ⁷Centrum Terapii Wspolczesnej J.M. Jasnorzewska sp., Bialystok, Poland, ⁸Revmacentrum MUDr.Mostera sro, Brno, Czech Republic, ⁹Samsung Bioepis Co., Ltd., Incheon, South Korea
Background/Purpose: SB4 is approved by the European Medicines Agency as a biosimilar of the reference etanercept (ETN). Long term safety and efficacy of SB4 up…
Abstract Number: 604 • 2016 ACR/ARHP Annual Meeting
Sustained Efficacy and Comparable Safety and Immunogenicity after Transition to SB5 (an Adalimumab Biosimilar) Vs. Continuation of SB5 or Reference Adalimumab (Humira®) in Patients with Rheumatoid Arthritis: Results of Phase III Study
Michael Weinblatt¹, Asta Baranauskaite², Jaroslaw Niebrzydowski³, Eva Dokoupilova⁴, Agnieszka Zielinska⁵, Karina Sitek-Ziolkowska⁶, Janusz Jaworski⁷, Artur Racewicz⁸, Margarita Pileckyte², Krystyna Jedrychowicz-Rosiak⁹, Vyacheslav Zhdan¹⁰, Soo Yeon Cheong¹¹ and Jeehoon Ghil¹¹, ¹Brigham and Women’s Hospital, Boston, MA, ²Lithuanian University of Health Sciences, Kaunas, Lithuania, ³Medica Pro Familia, Gdynia, Poland, ⁴MEDICAL PLUS s.r.o, Uherske Hradiste, Czech Republic, ⁵Medica Pro Familia Sp. z o.o. Spolka Komandytowo-Akcyjna, Warszawa, Poland, ⁶Medica pro Familia, Katowice, Poland, ⁷Reumatika Centrum Reumatologi, Warszawa, Poland, ⁸Zdrowie Osteo- Medic s.c, Bialystok, Poland, ⁹Przychodnia Neuromedyka, Zyrardów, Poland, ¹⁰M.V.Sklifosovskyi Poltava Regional Clinical Hospital, Poltava, Ukraine, ¹¹Samsung Bioepis Co., Ltd., Incheon, South Korea
Background/Purpose: SB5 has been developed as a biosimilar of the reference adalimumab (ADL). The 24-week results of the phase III study have been reported.1 Efficacy,…
Abstract Number: 621 • 2016 ACR/ARHP Annual Meeting
Effectiveness and Safety of CT- P13 (Biosimilar Reference Infliximab) in a Real-Life Setting in 151 Patients with Rheumatoid Arthritis and Ankylosing Spondylitis: A Mid-Term Interim Analysis
Catalin Codreanu¹, Klara Sirova², Katerina Jarosova³ and Anastas Batalov⁴, ¹Rheumatology, 'Dr. Ion Stoia' Clinical Center of Rheumatic Diseases, Bucharest, Romania, ²Revmatologie, Revmatologie MU Dr. Klara Sirova, sro, Ostrava, Czech Republic, ³Institute of Rheumatology, Prague, Czech Republic, ⁴Rheumatology, Medical University of Plovdiv, UMHAT Kaspela, Plovdiv, Bulgaria
Background/Purpose: Over the past decade, the use of biologics has significantly changed the management of rheumatoid arthritis (RA) and ankylosing spondylitis (AS). However, the high…
Abstract Number: 622 • 2016 ACR/ARHP Annual Meeting
Efficacy after Transition to SB5 from Reference Adalimumab (Humira®) Vs. Continuation of SB5 or Reference Adalimumab By Antibodies Developed after Transition from a SB5 Phase III Study
Mark C. Genovese¹, Michael Weinblatt², Edward C. Keystone³, Asta Baranauskaite⁴, Soo Yeon Cheong⁵ and Jeehoon Ghil⁵, ¹Stanford University Medical Center, Palo Alto, CA, ²Brigham and Women’s Hospital, Boston, MA, ³Mount Sinai Hospital, Toronto, ON, Canada, ⁴Lithuanian University of Health Sciences, Kaunas, Lithuania, ⁵Samsung Bioepis Co., Ltd., Incheon, South Korea
Background/Purpose : SB5 has been developed as a biosimilar of the reference adalimumab (ADL). The 52-week efficacy and safety results were reported previously. 1 Here…
Abstract Number: 627 • 2016 ACR/ARHP Annual Meeting
Clinical and Immunogenicity Outcomes after Switching Treatment from Innovator Infliximab to Biosimilar Infliximab in Rheumatic Diseases in Daily Clinical Practice
L Tweehuysen¹, B.J.F. van den Bemt², I.L. van Ingen³, A.J.L. de Jong⁴, W.H. van der Laan⁵, F.H.J. van den Hoogen⁵ and A.A. den Broeder⁵, ¹Sint Maartenskliniek Nijmegen, Nijmegen, Netherlands, ²Pharmacy, Sint Maartenskliniek Nijmegen, Nijmegen, Netherlands, ³Rheumatology, Radboudumc Nijmegen, Nijmegen, Netherlands, ⁴Department of Rheumatology, Rijnstate Arnhem, Arnhem, Netherlands, ⁵Department of Rheumatology, Sint Maartenskliniek, Nijmegen, Netherlands
Background/Purpose: Biosimilar infliximab is registered in Europe for the same therapeutic indications as innovator infliximab. In 2015, four rheumatology departments in the Netherlands decided to…
Abstract Number: 638 • 2016 ACR/ARHP Annual Meeting
A Randomized, Open-Label, Single-Dose, Parallel-Group Trial to Determine the Pharmacokinetics, Safety and Immunogenicity of GP2017, a Proposed Adalimumab Biosimilar, Following a Single Subcutaneous Injection By an Autoinjector or Prefilled Syringe in Healthy Male Subjects
Ellen Schuck¹, Julia Jauch¹, Alison Balfour¹, Jennifer Storck¹, Martin Rieger¹, Paul Martin¹, Andrej Skerjanec¹ and Maria Velinova², ¹Hexal AG, Holzkirchen, Germany, ²PRA Health Sciences, Zuidlaren, Netherlands
Background/Purpose: The purpose of this study was to describe the pharmacokinetics (PK), safety and immunogenicity of GP2017, a proposed adalimumab biosimilar, administered as a single…
Abstract Number: 642 • 2016 ACR/ARHP Annual Meeting
Quality of Life Outcomes Following Therapy with Chs-0214 and Etanercept (Enbrel): Randomized, Double-Blind Study in Subjects with Rheumatoid Arthritis
Alan J. Kivitz^1,2, James R. O'Dell³, Tsutomu Takeuchi⁴, Yoshiya Tanaka⁵, Satoshi Nakashima⁶, Cass Kelleher⁷, Jennifer Hodge⁸, Barbara Finck⁷ and RApsody Study Group, ¹Altoona Center for Clinical Research, Duncansville, PA, ²Altoona Arthritis & Osteoporosis Center, Duncansville, PA, ³Department of Internal Medicine, University of Nebraska Medical Center, Omaha, NE, ⁴Division of Rheumatology, Department of Internal Medicine,, Keio University School of Medicine, Tokyo, Japan, ⁵The First Department of Internal Medicine,, School of Medicine, University of Occupational and Environmental Health, Kitakyushu, Japan, ⁶Daiishi Sankyo, Shinagawa-Ku Tokyo, Japan, ⁷Clinical Science, Coherus BioSciences, Redwood City, CA, ⁸Coherus BioSciences, Redwood City, CA
Background/Purpose: CHS-0214 is in development as a proposed biosimilar of etanercept. This Phase III confirmatory, safety and efficacy study randomized and dosed 644 subjects with…
Abstract Number: 721 • 2016 ACR/ARHP Annual Meeting
Safety and Efficacy of Switching from Originator to CT-P13 Infliximab Biosimilar in Patients Affected By Spondyloarthritis. a 6-Month Observational Study
Alberto Batticciotto^1,2, Marco Antivalle², Francesca Li Gobbi³, Simone Parisi⁴, Rossella Talotta², Valentina Varisco², Maurizio Benucci³, Enrico Fusaro⁴ and Piercarlo Sarzi-Puttini¹, ¹Rheumatology Unit, ASST Fatebenefratelli - Sacco, L. Sacco University Hospital, Milano, Italy, ²Rheumatology Unit, ASST Fatebenefratelli - Sacco, L. Sacco University Hospital, Milan, Italy, ³Rheumatology Unit, Ospedale S. Giovanni di Dio, Florence, Florence, Italy, ⁴Department of Rheumatology, University Hospital Città Della Salute e della Scienza di Torino, Turin, Italy
Background/Purpose: Biosimilar infliximab (INX) was recently approved by the European Medicine Agency based on comparable pharmacokinetics, safety and efficacy profile to innovator INX for the…
Abstract Number: 1634 • 2016 ACR/ARHP Annual Meeting
Pharmacokinetics and Safety of Three Formulations of Rituximab (CT-P10, US-sourced Innovator Rituximab and EU-sourced Innovator Rituximab) in Patients with Rheumatoid Arthritis: Results from Phase 3 Randomized Controlled Trial over 24 Weeks
Chang-Hee Suh¹, Alfredo Berrocal Kasay², Elias Chalouhi El-Khouri³, Pedro Miranda⁴, Ljubinka Bozic Majstorovic⁵, Slawomir Jeka⁶, Pawel Hrycaj⁷, Dmytro Rekalov⁸, Piotr Wiland⁹, Andreas Krause¹⁰, Istvan Szombati¹¹, Anna Mihailova¹², Ihor Hospodarskyy¹³, Mariusz Piotrowski¹⁴, Seong-Ryul Kwon¹⁵, Eun-Young Lee¹⁶, Dae-Hyun Yoo¹⁷, Won Park¹⁸, Seung-Cheol Shim¹⁹, Sang-Joon Lee²⁰ and Taek S. Kwon²⁰, ¹Department of Rheumatology, Ajou University School of Medicine, Suwon, Korea, The Republic of, ²ABK Reuma SRL – Medicentro Biociencias, Lima, Peru, ³Clinica Internacional, Lima, Peru, ⁴Centro De Estudios Reumatológicos, Santiago, Chile, ⁵Clinical Centre Banja Luka, Bonja Luka, Bosnia and Herzegovina, ⁶Department of Rheumatology and Connective Tissue Diseases, 2nd University Hospital, CM UMK, Bydgoszcz, Poland, ⁷Rheumatology and Clinical Immunology, Poznañ University of Medical Sciences, Poznan, Poland, ⁸Department of Internal Diseases, Zaporizhzhia Regional Hospital, Zaporozhe, Ukraine, ⁹Uniwersytecki Szpital Kliniczny im. Jana Mikulicza- Radeckigo, Wroclaw, Poland, ¹⁰Medical Centre for Rheumatology Berlin-Buch, Immanuel Krankenhaus Berlin, Berlin, Germany, ¹¹QUALICLINIC Kft., Budapest, Hungary, ¹²Orto clinic Ltd., Riga, Latvia, ¹³Ternopil State Medical University, Ternopil, Ukraine, ¹⁴Rheumatology and Connective Tissue Diseases, Medical University of Lublin, Poland, Lublin, Poland, ¹⁵Internal Medicine/Rheumatology, Inha University Hospital, Incheon, South Korea, ¹⁶Division of Rheumatology, Department of Internal Medicine, Seoul National University Hospital, Seoul, Korea, The Republic of, ¹⁷Department of Rheumatology, Hanyang University Hospital for Rheumatic Diseases, Seoul, South Korea, ¹⁸Division of Rheumatology, Department of Internal Medicine, Inha University Hospital, Incheon, South Korea, ¹⁹Department of Internal Medicine, Chungnam National University Hospital, Daejeon, South Korea, ²⁰CELLTRION, Inc., Incheon, South Korea
Pharmacokinetics and Safety of Three Formulations of Rituximab (CT-P10, US-sourced Innovator Rituximab and EU-sourced Innovator Rituximab) in Patients with Rheumatoid Arthritis: Result from Phase 3…
Abstract Number: 438 • 2015 ACR/ARHP Annual Meeting
Comparison of the Stanford and Indian Health Assessment Questionnaires for Disability Outcomes in a Phase 3, Randomized, Double-Blind, Active Comparator Study of Infliximab and Biosimilar Infliximab BOW15 in Rheumatoid Arthritis
Arvind Chopra¹, Manjit Saluja², Alastair Knight³, Lucy Shneyer⁴, Cheryl Lassen⁵, Michael Wyand⁶ and Jonathan Kay⁷, ¹Rheumatology, Centre for Rheumatic Diseases, Pune 411001, India, ²Centre for Rheumatic Diseases, Pune 411001, India, ³Data Management, Evicom Ltd, Twickenham, United Kingdom, ⁴Shneyer Statistics, Denville, NJ, ⁵Epirus Biopharmaceuticals, Zug, Switzerland, ⁶Epirus Biopharmaceuticals, Boston, MA, ⁷University of Massachussets Medical School, Worcester, MA
Background/Purpose: The Stanford Health Assessment Questionnaire (HAQ) includes several questions that are more relevant to rheumatoid arthritis (RA) patients in Western countries than to those…
Abstract Number: 1221 • 2015 ACR/ARHP Annual Meeting
Characteristics and Outcomes of RA Patients Who Start Biosimilar Infliximab in South Korea
Yoon-Kyoung Sung¹, Soo-Kyung Cho¹, Soyoung Won², Chan-Bum Choi³, So-Young Bang⁴, Seung-Jae Hong⁵, Hyoun-Ah Kim⁶, Eunmi Koh⁷, Hye-Soon Lee⁸, Chang-Hee Suh⁹, Dae-Hyun Yoo¹⁰, Sang-Cheol Bae¹ and BIOPSY investigators, ¹Department of Rheumatology, Hanyang University Hospital for Rheumatic Diseases, Clinical Research Center for Rheumatoid Arthritis (CRCRA), Seoul, South Korea, ²Clinical Research Center for Rheumatoid Arthritis (CRCRA), Seoul, South Korea, ³Hanyang University Hospital for Rheumatic Diseases, Clinical Research Center for Rheumatoid Arthritis (CRCRA), Seoul, South Korea, ⁴Hanyang University Guri Hospital, Guri, South Korea, ⁵Division of Rheumatology, Department of Internal Medicine, Kyung Hee University Hospital, Seoul, South Korea, ⁶Ajou University Hospital, Suwon, South Korea, ⁷Department of Medicine, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, South Korea, ⁸Department of Rheumatology, Hanyang University Guri Hospital, Guri, South Korea, ⁹Department of Rheumatology, Ajou University Hospital, Suwon, South Korea, ¹⁰Department of Rheumatology, Hanyang University Hospital for Rheumatic Diseases, Seoul, South Korea
Background/Purpose: Recently biosimilar infliximab was approved in South Korea and it has been commonly used for rheumatoid arthritis (RA) patients who are resistant to conventional…
Abstract Number: 1273 • 2015 ACR/ARHP Annual Meeting
Uptake of the First Biosimilar Infliximab Since Its Approval in South Korea
Seoyoung C. Kim¹, Nam-Kyong Choi², Joongyub Lee², Kyoung-Eun Kwon³, Wesley Eddings⁴, Yoon-Kyoung Sung⁵, Hong Ji Song⁶, Aaron K. Kesselheim⁴ and Daniel H. Solomon⁷, ¹Div. of Pharmacoepidemiology and Pharmacoeconomics, Div. of Rheumatology, Immunology and Allergy, Brigham and Women's Hospital, Boston, MA, ²Seoul National University Hospital, Seoul, South Korea, ³Seoul National University College of Medicine, Seoul, South Korea, ⁴Division of Pharmacoepidemiology and Pharmacoeconomics, Brigham and Women's Hospital, Boston, MA, ⁵Hospital for Rheumatic Disease, Hanyang Univ Medical Center, Seoul, South Korea, ⁶Hallym University Sacred Heart Hospital, Anyang, South Korea, ⁷Division of Rheumatology, Immunology and Allergy, Brigham and Women's Hospital, Harvard Medical School, Boston, MA
Background/Purpose: Development of tumor necrosis factor (TNF) inhibitors has been a major advance in treatment of systemic inflammatory diseases, such as rheumatoid arthritis. While TNF…
Abstract Number: 1675 • 2015 ACR/ARHP Annual Meeting
Efficacy and Safety of Switched CT-P10 from Innovator Rituximab Compared to Those of Maintained CT-P10 in Patients with Rheumatoid Arthritis up to 56 Weeks
Dae-Hyun Yoo¹, Won Park², Chang-Hee Suh³, Seung-Cheol Shim⁴, Fidencio Cons Molina⁵, Slawomir Jeka⁶, Jan Brzezicki⁷, Francisco G. Medina-Rodriguez⁸, Pawel Hrycaj⁹, Piotr Wiland¹⁰, Eun Young Lee¹¹, Pavel Shesternya¹², Volodymyr Kovalenko¹³, Leysan Myasoutova¹⁴, Marina Stanislav¹⁵, Sebastiao Radominski¹⁶, Mie Jin Lim¹⁷, Jung-Yoon Choe¹⁸, Sung Young Lee¹⁹ and Sang Joon Lee²⁰, ¹Department of Rheumatology, Hanyang University Hospital for Rheumatic Diseases, Seoul, South Korea, ²Division of Rheumatology, Department of Internal Medicine, Inha University Hospital, Incheon, South Korea, ³Department of Rheumatology, Ajou University Hospital, Suwon, South Korea, ⁴Department of Internal Medicine, Chungnam National University Hospital, Daejeon, South Korea, ⁵Centro de Investigacion en Artritis y Osteoporosis, Mexicali, Mexico, ⁶University Hospital Nr 2 Dr. Jan Biziel, Collegium Medicum in Bydgoszcz, Nicolaus Copernicus University in Torun, Clinic of Rheumatology and Connective Tissue Diseases, Bydgoszcz, Poland, ⁷Wojewodzki Szpital Zespolony w Elablagu, Elblag, Poland, ⁸Rheumatology, LaSalle University, Mexico City, Mexico, ⁹Department of Rheumatology and Clinical Immunology, Poznan University of Medical Sciences, Poznan, Poland, ¹⁰Department of Rheumatology, Medical University of Wroclaw, Wroclaw, Poland, ¹¹Division of Rheumatology, Department of Internal Medicine, Seoul National University College of Medicine, Seoul, South Korea, ¹²Rheumatology Department, Krasnoyarsk State Medical University, Krasnoyarsk, Russia, ¹³Section of Non-coronarogenic Myocardial Diseases and Clinical Rheumatology, National Scientific Center, Kiev, Ukraine, ¹⁴City Reumatology Center, Research Medical Complex Vashe Zdorovie, Kazan, Russia, ¹⁵Research Rheumatology Institute n. a. V.A. Nassonova, Moscow, Russia, ¹⁶CETI-Centro de estudos em Terapias Inovadoras, Universidade Federal do Parana, Curitiba, Brazil, ¹⁷Division of Rheumatology, Departments of Internal Medicine, Inha University Hospital, Incheion, South Korea, ¹⁸Internal Medicine, Catholic University of Daegu, School of Medicine, Daegu, South Korea, ¹⁹Clinical Planning Department, CELLTRION, Inc., Incheon, South Korea, ²⁰CELLTRION, Inc., Incheon, South Korea
Background/Purpose: Pharmacokinetic (PK) equivalence and similarity of clinical efficacy, safety and immunogenicity up to week 24 were demonstrated between CT-P10, a biosimilar candidate for innovator…
Abstract Number: 2057 • 2015 ACR/ARHP Annual Meeting
Antibodies to Infliximab in Remicade-Treated Rheumatic Patients Show Identical Reactivity Towards Biosimilars
Begoña Ruiz-Argüello¹, Ainara Maguregui¹, Ainhoa Ruiz del Agua¹, Dora Pascual-Salcedo², Ana Martínez², Teresa Jurado³, Chamaida Plasencia⁴, Alejandro Balsa⁵, Francisca Llinares-Tello⁶, José Rosas⁷, Nerea Torres¹, Antonio Martínez¹ and Daniel Nagore¹, ¹R&D, Progenika-Grifols, Derio, Spain, ²Immunology Unit, La Paz University Hospital-Immunology, Madrid, Spain, ³Immunology, La Paz University Hospital-Idipaz, Madrid, Spain, ⁴Rheumatology Unit, La Paz University Hospital-Rheumatology, Madrid, Spain, ⁵Rheumatology, La Paz University Hospital-Rheumatology Department, Madrid, Spain, ⁶Clinical Analysis, Hospital Marina Baixa, Clinical Analysis, Villajoyosa, Spain, ⁷Rheumatology, Hospital Marina Baixa, Villajoyosa, Spain
Background/Purpose: Infliximab (IFX) is the most immunogenic of anti-TNFα drugs available to treat patients with rheumatic diseases. The recent approval of the first infliximab biosimilars in…

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