Abstracts tagged "bioequivalence"

Abstract Number: 0823 • ACR Convergence 2021
Pharmacokinetic and Pharmacodynamic Evaluation of a Proposed Biosimilar MSB11456 versus Both the US-licensed and EU-approved Tocilizumab: Results of a Randomized, Double-blind, Parallel-group, Single-dose Trial in Healthy Adults
Christian Schwabe¹, Chris Wynne², Andras Illes³, Martin Ullmann³, Emmanuelle Vincent³, Vishal Ghori³, Corinne Petit-Frere³, Anne-Sophie Racault³ and Joelle Monnet³, ¹Auckland Clinical Studies Ltd, Auckland, New Zealand, ²Christchurch Clinical Studies Trust Ltd, Christchurch, New Zealand, ³Fresenius Kabi SwissBioSim, Eysins, Switzerland
Background/Purpose: Tocilizumab, a biologic disease-modifying antirheumatic drug, is a recombinant humanized monoclonal immunoglobulin G1 antibody against the interleukin-6 receptor (IL-6R). MSB11456 is a proposed biosimilar…

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Abstracts tagged "bioequivalence"

Pharmacokinetic and Pharmacodynamic Evaluation of a Proposed Biosimilar MSB11456 versus Both the US-licensed and EU-approved Tocilizumab: Results of a Randomized, Double-blind, Parallel-group, Single-dose Trial in Healthy Adults