Adalimumab is a type of drug known as a biologic used for chronic inflammatory diseases, such as Crohn’s. In these medical conditions, a protein called TNF is overproduced in the affected part of the body, which causes inflammation and damage. Adalimumab blocks the action of TNF to reduce this inflammation.
The FDA defines a biosimilar as a biological product that is highly similar to and has no clinically meaningful differences in safety and effectiveness to an existing FDA-approved reference product. This means that there are more treatment options for chronically ill patients at a potentially lower cost.
BI 695501 is an adalimumab biosimilar that has already demonstrated similar efficacy, safety and immunogenicity to adalimumab reference product in patients with chronic plaque psoriasis and rheumatoid arthritis.
In this video, Professor Stephen Hanauer (Feinberg School of Medicine, Northwestern University) discusses the VOLTAIRE-CD study, which aimed to compare the safety and efficacy of the BI 695501 biosimilar in Crohn’s disease
Safety and efficacy of BI 695501 versus adalimumab reference product in patients with advanced Crohn’s disease (VOLTAIRE-CD): a multicentre, randomised, double-blind, phase 3 trial.
Stephen Hanauer, Bernd Liedert, Sigrid Balser, Ekkehard Brockstedt, Viktoria Moschetti & Stefan Schreiber.
The Lancet Gastroenterology & Hepatology (2021) doi.org/10.1016/S2468-1253(21)00252-1