Abstracts tagged "biosimilars and safety"

Abstract Number: 616 • 2016 ACR/ARHP Annual Meeting
ABP 501 Long-Term Safety/Efficacy: Interim Results from an Open-Label Extension Study
Stanley Cohen¹, Jose L. Pablos², Nan Zhang³, Warren Rizzo⁴, Gerhard Muller⁵, Devi Padmanaban⁶, Alan Kivitz⁷, Alan K. Matsumoto⁸ and Primal Kaur⁹, ¹Metroplex Clinical Research Center and University of Texas Southwestern Medical Center, Dallas, TX, ²Grupo de Enfermedades Inflamatorias y Autoinmunes, Instituto de Investigación Hospital 12 de Octubre (i+12), Madrid, Spain, ³Biosimilars, Amgen, Inc., Thousand Oaks, CA, ⁴Advanced Arthritis Care & Research, Scottsdale, AZ, ⁵Dept of Nephrology and Rheumatogy, University Medical Center Göttingen, Göttingen, NIEDERSACHSEN, Germany, ⁶Biosimilars, Amgen, Thousand Oaks, CA, ⁷Altoona Center for Clinical Research, Duncansville, PA, ⁸Rheumatology, Arthritis & Rheumatism Associate, Wheaton, MD, ⁹Amgen, Thousand Oaks, CA
Background/Purpose: This was a single-arm OLE of the parent study; the objective was to assess long-term safety and efficacy of ABP 501. The study…
Abstract Number: 2054 • 2015 ACR/ARHP Annual Meeting
Randomized, Double-Blind, Phase 3 Study of Efficacy and Safety of ABP 501 Compared with Adalimumab in Subjects with Moderate to Severe Rheumatoid Arthritis
Stanley B. Cohen¹, Mark C. Genovese², Ernest H. Choy³, Fernando Perez-Ruiz⁴, Jose L. Pablos⁵, Nan Zhang⁶ and Primal Kaur⁷, ¹Metroplex Clinical Research Center, Dallas, TX, ²Division of Rheumatology, Stanford University Medical Center, Palo Alto, CA, ³Cardiff University, Institute of Infection and Immunity, Tenovus Building, University Hospital of Wales, Cardiff, United Kingdom, ⁴Servicio de Reumatología, Vizcaya, Spain, ⁵Instituto de Investigacion Hospital, Madrid, Spain, ⁶Biosimilars, Amgen, Inc., Thousand Oaks, CA, ⁷Amgen, Inc., Thousand Oaks, CA
Background/Purpose: ABP 501 is being developed as a biosimilar candidate to adalimumab (Humira®), a fully human recombinant monoclonal antibody. Evidence from analytical comparisons indicates that…

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