The first patient has been enrolled into the VOLTAIRE-X interchangeability study, which seeks to demonstrate that BI 695501 is interchangeable with the U.S.-marketed formulation of Humira®* 40 mg/0.8 ml.
This is the first study in the U.S. to investigate an interchangeability designation for an adalimumab biosimilar candidate.
The study will compare the pharmacokinetics and clinical outcomes between patients receiving Humira® continuously, versus those who switch repeatedly between Humira® and BI 695501, Boehringer Ingelheim's adalimumab biosimilar candidate. The study will also assess safety, immunogenicity and efficacy.
The VOLTAIRE-X study (NCT03210259), is being conducted in 240 patients with moderate-to-severe chronic plaque psoriasis. Results from the study are expected in the second half of 2019.
BI 695501 has been accepted for regulatory review by the European Medicines Agency and the U.S. Food and Drug Administration. Phase III results demonstrating clinical equivalence of BI 695501 to Humira® in people living with rheumatoid arthritis were recently presented at the annual European Congress of Rheumatology.