Abstracts tagged "biosimilars and pharmacokinetics"

Abstract Number: 2443 • 2017 ACR/ARHP Annual Meeting
Randomized, Double-Blind, Single-Dose, Three-Arm Parallel Trial to Determine the Pharmacokinetics and Safety of GP2017, EU- and US-Adalimumab in Healthy Male Subjects
Julia Jauch-Lembach¹, Andrej Skerjanec¹, Halimuniyazi Haliduola¹, Nicole Hass¹, Oliver von Richter¹, Rainard Fuhr² and Thomas Koernicke², ¹Hexal AG, Holzkirchen, Germany, ²PAREXEL International GmbH, Berlin, Germany
Background/Purpose: GP2017 is a proposed adalimumab biosimilar that has been shown to be similar to reference adalimumab at an analytical and preclinical level. The aim…
Abstract Number: 482 • 2016 ACR/ARHP Annual Meeting
Comparison of Nonclinical Pharmacology, Pharmacodynamics and Efficacy Response of the Proposed Adalimumab Biosimilar GP2017 to Originator Adalimumab
Antonio Dasilva¹, Ulrich Kronthaler¹, Hans-Peter Hofmann², Vera Koppenburg¹, Melanie Baron³, Cornelius Fritsch⁴, Otmar Hainzl¹ and Andreas Seidl¹, ¹Sandoz Biopharmaceuticals, Holzkirchen, Germany, ²Pre-clinical, Sandoz Biopharmaceuticals, Holzkirchen, Germany, ³Clinical Development, Sandoz Biopharmaceuticals, Holzkirchen, Germany, ⁴Bioassay Support Global Development, Novartis Pharma AG, Basel, Switzerland
Background/Purpose: Biosimilars are created to be essentially the same as their reference marketed biopharmaceuticals which have lost exclusivity, and they aim to offer more affordable…
Abstract Number: 1504 • 2014 ACR/ARHP Annual Meeting
Pharmacokinetic Equivalence of ABP 501 Relative to Adalimumab: Results from a Randomized, Single-Blind, Single-Dose, Parallel Group Study in Healthy Subjects
Primal P. Kaur¹, Vincent Chow², Nan Zhang³, Mike Moxness⁴ and Richard Markus³, ¹Amgen, Inc., Thousand Oaks, CA, ²Pharmacokinetics and Drug Metabolism, Amgen, Inc., Seattle, WA, ³Biosimilars, Amgen, Inc., Thousand Oaks, CA, ⁴Clinical Immunology and BSM, Amgen, Inc., Thousand Oaks, CA
Background/Purpose Adalimumab is a recombinant IgG1 monoclonal antibody that binds to TNFα blocking its interaction with p55 and p75 cell surface receptors. ABP 501 is…

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