Abstracts tagged "biosimilarity"

Abstract Number: 462 • 2017 ACR/ARHP Annual Meeting
ABP 710: Matching Critical Biological Functions with Infliximab
Robert Sandrock¹, Palanisamy Kanakaraj² and Scott Kuhns¹, ¹Amgen, Inc., Thousand Oaks, CA, ²Amgen, Inc., Cambridge, MA
Background/Purpose: ABP 710 is being developed as a biosimilar to infliximab, a recombinant chimeric monoclonal antibody that binds tumor necrosis factor alpha (TNFa) and inhibits…
Abstract Number: 2495 • 2017 ACR/ARHP Annual Meeting
Biosimilarity between Humira® and the Biosimilar Candidate SB5 in Product Quality
Nayoung Lee, Minlee Kim, JongAh Joanne Lee, Soohwan Kim and Hahymn Yang, Samsung Bioepis, Incheon, Korea, Republic of (South)
Background/Purpose: A biosimilar is a biopharmaceutical product that is highly similar to an already licensed one in terms of quality, safety, and efficacy. We (Samsung…
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: 1862 • 2013 ACR/ARHP Annual Meeting
Target-Directed Development Of a Proposed Biosimilar Etanercept, GP2015: Comparability Of In Vitro Target Binding and Pre-Clinical Efficacy and Pharmacokinetics
Antonio da Silva¹, Ulrich Kronthaler¹, Cornelius Fritsch², Johann Poetzl³, Adelheid Rohde⁴, Anastassia Papandrikopoulou⁵, Hans-Peter Hofmann⁶ and Jan Marinus Visser¹, ¹Preclinical Development, Sandoz Biopharmaceuticals / HEXAL AG, Holzkirchen, Germany, ²Bioassay Support Global Development, Novartis Pharma AG, Basel, Switzerland, ³Bioanalytics, Sandoz Biopharmaceuticals/Hexal AG, Oberhaching, Germany, ⁴Characterisation, Sandoz Biopharmaceuticals/Hexal AG, Kundl, Austria, ⁵Medical Communications, Sandoz Biopharmaceuticals / HEXAL AG, Holzkirchen, Germany, ⁶Pre-clinical, Sandoz Biopharmaceuticals/Hexal AG, Holzkirchen, Germany
Background/Purpose: Biosimilars are copy versions of existing biologic medicines that have lost patent exclusivity and are approved via stringent regulatory pathways. Biosimilars are designed to…
Abstract Number: L15 • 2013 ACR/ARHP Annual Meeting
Efficacy and Safety of CT-P13 (Infliximab Biosimilar) over Two Years in Patients with Ankylosing Spondylitis: Comparison Between Continuing with CT-P13 and Switching from Infliximab to CT-P13
Won Park¹, Pedro Miranda², Marek Brzosko³, Piotr Wiland⁴, Sergio Gutierrez-Ureña⁵, Helena Mikazane⁶, Yeon-Ah Lee⁷, Svitlana Smiyan⁸, Mie-Jin Lim¹, Vladimir Kadinov⁹, Carlos Abud-Mendoza¹⁰, YoungKi Son¹¹, Dae-Hyun Yoo¹² and Jürgen Braun¹³, ¹Division of Rheumatology, Department of Internal Medicine, Inha University Hospital, Incheon, South Korea, ²Universidad de Chile and Centro de Estudios Reumatologicos, Santiago de Chile, Chile, ³Department of Rheumatology and Internal Diseases, Department of Rheumatology and Internal Diseases Pomeranian Medical University in Szczecin, Szczecin, Poland, ⁴Department of Rheumatology, Medical University of Wroclaw, Wroclaw, Poland, ⁵Antiguo Hospital Civil de Guadalajara, Guadalajara, Mexico, ⁶Outpatient Clinic 'ORTO', Riga, Latvia, ⁷Division of Rheumatology, Department of Internal Medicine, Kyung Hee University, Seoul, South Korea, ⁸Municipal Institution of Ternopil Regional Council "Ternopil University Hospital", Ternopil, Ukraine, ⁹Multiprofile Hospital for Active Treatment 'Sv. Marina', Varna, Bulgaria, ¹⁰Hospital Central Dr. Ignacio Morones Prieto, San Luis Potosyi, Mexico, ¹¹CELLTRION, Incheon, South Korea, ¹²Rheumatology, Hanyang University Hospital for Rheumatic Diseases, Seoul, South Korea, ¹³PsAID taskforce, EULAR, Zurich, Switzerland
Background/Purpose: CT-P13 is an infliximab (INX) biosimilar recently approved by the European Medicine Agency. PLANETAS was a 54-week (wk) randomized double-blind parallel group multicenter Phase…
Abstract Number: L1 • 2013 ACR/ARHP Annual Meeting
Efficacy and Safety of CT-P13 (Infliximab biosimilar) over Two Years in Patients with Rheumatoid Arthritis: Comparison Between Continued CT-P13 and Switching from Infliximab to CT-P13
Dae-Hyun Yoo¹, Nenad Prodanovic², Janusz Jaworski³, Pedro Miranda⁴, Edgar B. Ramiterre⁵, Allan Lanzon⁶, Asta Baranauskaite⁷, Piotr Wiland⁸, Carlos Abud-Mendoza⁹, Boycho Oparanov¹⁰, Svitlana Smiyan¹¹, YoungKi Son¹², Won Park¹³ and Ulf Müller-Ladner¹⁴, ¹Rheumatology, Hanyang University Hospital for Rheumatic Diseases, Seoul, South Korea, ²Clinical Center Banja Luka, Banja Luka, Bosnia, ³Reumatika Centrum Reumatologi, Warszawa, Poland, ⁴Universidad de Chile and Centro de Estudios Reumatologicos, Santiago de Chile, Chile, ⁵Brokenshire Memorial Hospital, Davao City, Philippines, ⁶Mary Mediatrix Medical Center, Batangas, Philippines, ⁷Hospital of Lithuanian University of Health Sciences Kaunas Clinics, Kaunas, Lithuania, ⁸Department of Rheumatology, Medical University of Wroclaw, Wroclaw, Poland, ⁹Hospital Central Dr. Ignacio Morones Prieto, San Luis Potosyi, Mexico, ¹⁰Military Medical Academy, Sofia, Bulgaria, ¹¹Municipal Institution of Ternopil Regional Council "Ternopil University Hospital", Ternopil, Ukraine, ¹²CELLTRION, Incheon, South Korea, ¹³Division of Rheumatology, Department of Internal Medicine, Inha University Hospital, Incheon, South Korea, ¹⁴Internal Medicine and Rheumatology, Justus-Liebig-University of Gießen, Kerckhoff-Klinik, Bad Nauheim, Germany
Background/Purpose: CT-P13 is a biosimilar of infliximab (INX), approved by the European Medicines Agency. The objective of this open-label Phase 3 extension study was to…

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