Abstracts tagged "biosimilars"

Abstract Number: 2058 • 2015 ACR/ARHP Annual Meeting
Efficacy and Safety of Rituximab Biosimilar Candidate (CT-P10) and Innovator Rituximab in Patients with Rheumatoid Arthritis: Results from Phase I Randomized Controlled Trial over 72 Weeks
Dae-Hyun Yoo¹, Won Park², Chang-Hee Suh³, Seung-Cheol Shim⁴, Slawomir Jeka⁵, Fidencio Cons Molina⁶, Pawel Hrycaj⁷, Wolfgang Spieler⁸, Piotr Wiland⁹, Jan Brzezicki¹⁰, Eun Young Lee¹¹, Francisco G. Medina-Rodriguez¹², Pavel Shesternya¹³, Sebastiao Radominski¹⁴, Marina Stanislav¹⁵, Volodymyr Kovalenko¹⁶, Donghyuk Sheen¹⁷, Leysan Myasoutova¹⁸, Mie Jin Lim¹⁹, Jung-Yoon Choe²⁰, Taek S. Kwon²¹ and Sang Joon Lee²¹, 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, ⁵University Hospital Nr 2 Dr. Jan Biziel, Collegium Medicum in Bydgoszcz, Nicolaus Copernicus University in Torun, Clinic of Rheumatology and Connective Tissue Diseases, Bydgoszcz, Poland, ⁶Centro de Investigacion en Artritis y Osteoporosis, Mexicali, Mexico, ⁷Department of Rheumatology and Clinical Immunology, Poznan University of Medical Sciences, Poznan, Poland, ⁸Osteologie und Rheumatologie, ZeFOR GmbH Zentrum für Forschung, Zerbst, Germany, ⁹Department of Rheumatology, Medical University of Wroclaw, Wroclaw, Poland, ¹⁰Wojewodzki Szpital Zespolony w Elablagu, Elblag, Poland, ¹¹Division of Rheumatology, Department of Internal Medicine, Seoul National University College of Medicine, Seoul, South Korea, ¹²Rheumatology, LaSalle University, Mexico City, Mexico, ¹³Rheumatology Department, Krasnoyarsk State Medical University, Krasnoyarsk, Russia, ¹⁴CETI-Centro de estudos em Terapias Inovadoras, Universidade Federal do Parana, Curitiba, Brazil, ¹⁵Research Rheumatology Institute n. a. V.A. Nassonova, Moscow, Russia, ¹⁶Section of Non-coronarogenic Myocardial Diseases and Clinical Rheumatology, National Scientific Center, Kiev, Ukraine, ¹⁷Rheumatology, Eulji University Hospital, Daejeon, South Korea, ¹⁸City Reumatology Center, Research Medical Complex Vashe Zdorovie, Kazan, Russia, ¹⁹Division of Rheumatology, Departments of Internal Medicine, Inha University Hospital, Incheion, South Korea, ²⁰Internal Medicine, Catholic University of Daegu, School of Medicine, Daegu, South Korea, ²¹CELLTRION, Inc., Incheon, South Korea
Background/Purpose: CT-P10 is a biosimilar candidate of innovator rituximab (RTX). PK profile and clinical data up to week 24 has been reported at ACR 20131.…
Abstract Number: 2727 • 2015 ACR/ARHP Annual Meeting
BI 695501, a Proposed Biosimilar for Adalimumab, Shows Bioequivalence to Adalimumab Reference Products in a Randomized, Double-Blind Phase I Trial in Healthy Subjects
Christopher Wynne¹, Magdalena Petkova², Ferdinand Rombout³, Niklas Czeloth³, Mario Altendorfer³, Benjamin Lang⁴, Francois-Xavier Frapaise³ and Rod Ellis-Pegler⁵, ¹Christchurch Clinical Studies Trust, Christchurch, New Zealand, ²SGS, CPU Antwerpen, Antwerp, Belgium, ³Boehringer Ingelheim, Ingelheim, Germany, ⁴Boehringer Ingelheim, Biberach an der Riss, Germany, ⁵Auckland Clinical Studies Limited, Auckland, New Zealand
Background/Purpose: BI 695501 is a proposed adalimumab biosimilar currently in development and was evaluated for pharmacokinetic (PK) similarity to both US-licensed and EU-approved reference products.…
Abstract Number: 2825 • 2014 ACR/ARHP Annual Meeting
A Randomized, Double-Blind, Phase 3 Equivalence Trial Comparing the Etanercept Biosimilar, HD203, with Etanercept (Enbrel^®), in Combination with Methotrexate (MTX) in Patients with Rheumatoid Arthritis (RA)
Sang-Cheol Bae¹, Jinseok Kim², Jung-Yoon Choe³, Won Park⁴, So-Ra Lee⁵, Yongho Ahn⁶ and Yunjeong Seo⁷, ¹Department of Rheumatology, Hanyang University Hospital for Rheumatic Diseases, Seoul, South Korea, ²Division of Rheumatology, Internal Medicine, Jeju National University, Jeju, Korea, South Korea, ³Division of Rheumatology, Catholic University of Daegu School of Medicine, Daegu, South Korea, ⁴Medicine/Rheumatology, Inha University Hospital, Incheon, South Korea, ⁵Clinical Development/Regulatory Affairs, Hanwha Chemical, Seoul, South Korea, ⁶R&D Center, Hanwha Chemical, Daejeon, South Korea, ⁷Clinical Development, Hanwha Chemical, Seoul, South Korea
Background/Purpose Etanercept is a recombinant fusion protein that blocks TNF activity. HD203 is a biosimilar of etanercept. In a double-blind, randomized study in healthy volunteers,…
Abstract Number: 1509 • 2014 ACR/ARHP Annual Meeting
A Randomized, Double-Blind, Three-Arm, Parallel Group, Single-Dose Study to Compare the Pharmacokinetics, Safety, and Tolerability of Three Formulations of Infliximab (CT-P13, EU-sourced Infliximab and US-sourced Infliximab) in Healthy Volunteers
Dae-Hyun Yoo¹, Won Park², Seung-Cheol Shim³, Chang-Hee Suh⁴, Jihye Yun⁵ and Tina Pyo⁵, 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, ³Chungnam National University Hospital, Daejeon, South Korea, ⁴Allergy-Rheumatology, Ajou University Hospital, Suwon, South Korea, ⁵CELLTRION, Inc, Incheon, South Korea
Background/Purpose CT-P13 has been approved as the first biosimilar to innovator infliximab sourced from European Union (EU‑INX) in Sep 2013. Even if it has been…
Abstract Number: 1508 • 2014 ACR/ARHP Annual Meeting
Impact of Anti-Drug Antibody on Efficacy and Safety over Week 24 in Both CT-P10 and Innovator Rituximab Treatment Groups
Dae-Hyun Yoo¹, Won Park², Slawomir Jeka³, Fidencio Cons Molina⁴, Pawel Hrycaj⁵, Piotr Wiland⁶, Wolfgang Spieler⁷, Eun Young Lee⁸, Francisco G. Medina-Rodriguez⁹, Pavel Shesternya¹⁰, Sebastiao Radominski¹¹, Dong Hyuk Sheen¹², Mie Jin Lim¹³, Jung-Yoon Choe¹⁴, Leysan Myasoutova¹⁵, Taek Kwon¹⁶, Sang Joon Lee¹⁶, Seung-Cheol Shim¹⁷ and Chang-Hee Suh¹⁸, 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, ³University Hospital Nr 2 Dr. Jan Biziel, Collegium Medicum in Bydgoszcz, Nicolaus Copernicus University in Torun, Clinic of Rheumatology and Connective Tissue Diseases, Bydgoszcz, Poland, ⁴Centro de Investigacion en Artritis y Osteoporosis, Mexicali, Mexico, ⁵Department of Rheumatology and Clinical Immunology, Poznan University of Medical Sciences, Poznan, Poland, ⁶Department of Rheumatology, Medical University of Wroclaw, Wroclaw, Poland, ⁷Osteologie und Rheumatologie, ZeFOR GmbH Zentrum für Forschung, Zerbst, Germany, ⁸Internal Medicine, Seoul National University College of Medicine, Seoul, South Korea, ⁹Centro de Investigación Farmacológica y Biotecnológica, Mexico City, Mexico, ¹⁰Rheumatology Department, Krasnoyarsk State Medical University, Krasnoyarsk, Russia, ¹¹CETI-Centro de estudos em Terapias Inovadoras, Universidade Federal do Parana, Curitiba, Brazil, ¹²Rheumatology, Eulji University Hospital, DaeJeon, South Korea, ¹³Division of Rheumatology, Department of Internal Medicine,, Inha University Hospital, Incheon, South Korea, ¹⁴Division of Rheumatology, Catholic University of Daegu School of Medicine, Daegu, South Korea, ¹⁵City Reumatology Center, Research Medical Complex Vashe Zdorovie, Kazan, Russia, ¹⁶CELLTRION, Inc., Incheon, South Korea, ¹⁷Department of Internal Medicine, Chungnam National University Hospital, Daejeon, South Korea, ¹⁸Allergy-Rheumatology, Ajou University Hospital, Suwon, South Korea
Background/Purpose CT-P10 is a biosimilar candidate for rituximab. Pharmacokinetic equivalence and similarity of clinical efficacy, safety and immunogenicity had been demonstrated between CT-P10 and Innovator…
Abstract Number: 1505 • 2014 ACR/ARHP Annual Meeting
The Biosimilar Landscape: A Systematic Review of Its Current Status
Niti Goel^1,2 and Kamali Chance³, ¹Rheumatology Center of Excellence, Quintiles, Durham, NC, ²Duke University Medical Center, Durham, NC, ³Global Biosimilars Unit, Quintiles, Durham, NC
Background/Purpose In the last 5 years, the number of biosimilars in development for the treatment of immunologic diseases has increased as innovator etanercept (ETA), infliximab (IFX), adalimumab…
Abstract Number: 1502 • 2014 ACR/ARHP Annual Meeting
A Phase I Trial Comparing PF-05280586 (A Potential Biosimilar) and Rituximab in Subjects with Active Rheumatoid Arthritis
Jean-Claude P. Becker¹, Donghua Yin², Lisa Ann Melia³, Ruifeng Li⁴, Barry Gumbiner⁵, Dolca Thomas⁶, George Spencer-Green⁷ and Xu Meng², ¹Pfizer Biosimilars Research and Development/Medical Affairs., Pfizer Inc., New York, NY, ²Clinical Pharmacology/Pharmacometrics, Pfizer Inc., San Diego, CA, ³Biotechnology Clinical Development, Pfizer Inc., San Diego, CA, ⁴Biostatistics, Pfizer Inc., Cambridge, MA, ⁵Worldwide Research and Development, Pfizer Inc., San Diego, CA, ⁶Biosimilars Research and Development Unit, Pfizer Inc., New York, NY, ⁷Worldwide Research and Development, Pfizer Inc., Cambridge, MA
Background/Purpose: PF-05280586, a proposed biosimilar to rituximab, has the same primary amino acid sequence as rituximab with similar physicochemical and in vitro functional properties. This…
Abstract Number: 1501 • 2014 ACR/ARHP Annual Meeting
Immunogenicity Assessment of PF-06438179, a Potential Biosimilar to Infliximab, in Healthy Volunteers
Chandrasekhar Udata¹, Donghua Yin², Chun-hua Cai³, Stephanie Salts⁴, Steven Y. Hua⁴, Muhammad I. Rehman⁵ and Xu Meng², ¹Clinical Pharmacology, Pfizer Inc., San Diego, CA, ²Clinical Pharmacology/Pharmacometrics, Pfizer Inc., San Diego, CA, ³Pfizer Inc., Groton, CT, ⁴Pfizer Inc., San Diego, CA, ⁵Pfizer Inc., Cambridge, MA
Background/Purpose: PF-06438179, a proposed biosimilar to infliximab, was evaluated for immunogenicity in a phase 1 pharmacokinetic (PK) similarity study. Methods: In this double-blind trial (NCT01844804),…
Abstract Number: 1166 • 2014 ACR/ARHP Annual Meeting
5 Year Budget Impact Analysis of Biosimilar Infliximab for the Treatment of Rheumatoid Arthritis in UK, Italy, France and Germany
JiSeon Kim¹, JungAn Hong¹ and Alex Kudrin², ¹CELLTRION HEALTHCARE, INCHEON, South Korea, ²CELLTRION, Inc., Incheon, South Korea
Background/Purpose: Biosimilar infliximab has been approved by EMA based on comparable quality, safety and efficacy profile to infliximab for the management of inflammatory autoimmune disorders…
Abstract Number: L20 • 2014 ACR/ARHP Annual Meeting
BOW015, a Biosimilar Infliximab, in Patients with Active Rheumatoid Arthritis on Stable Methotrexate Doses: 54-Week Results of a Randomized, Double-Blind, Active Comparator Study
Jonathan Kay¹, Michael Wyand², Srikantiah Chandrashekara³, Davy Jacob Olakkengil⁴, Kaushik Bhojani⁵, Girish Bhatia⁶, Gaurav Rathi⁷, Suresh Maroli⁸, Elizabeth Thomson⁹, Cheryl Lassen¹⁰, Lucy Shneyer¹¹ and Arvind Chopra¹², ¹UMass Memorial Medical Center, Worcester, MA, ²Epirus Biopharmaceuticals, Boston, MA, ³Chanre Rheumatology and Immunology Centre and Research, Bangalore, India, ⁴St. John’s Medical College Hospital, Bengaluru, India, ⁵Department of Rheumatology, Fortis Hospital, Mumbai, India, ⁶Pentagon Multispeciality Clinic and Research Centre, Pune, India, ⁷Rathi Hospital, Ahmedabad, India, ⁸Reliance Life Sciences, Mumbai, India, ⁹Elizabeth Thomson LTD, London, MA, United Kingdom, ¹⁰Epirus Biopharmaceuticals, Zug, Switzerland, ¹¹Shneyer Statistics LLC, Denville, NJ, ¹²Rheumatology, Center for Rheumatic Diseases, Pune, India
Background/Purpose: Over the first 16 wks of this phase 3 double-blind (DB) comparative effectiveness clinical trial, the comparable proportion of ACR20 responders for BOW015 (a…

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