Boehringer Ingelheim initiates interchangeability trial of BI 695501 and Humira


Boehringer Ingelheim has initiated patient enrolment in an interchangeability clinical trial (VOLTAIRE-X) of its product candidate BI 695501 and the US-marketed formulation of 40mg/0.8mL Humira.

BI 695501 is an adalimumab biosimilar candidate accepted for regulatory review by the European Medicines Agency (EMA) and the US Food and Drug Administration (FDA).

Humira is the trade name of adalimumab that features tumour necrosis factor (TNF) inhibition, anti-inflammatory properties and is a biologic medication indicated for the treatment of rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis, Crohn's disease and ulcerative colitis among others.

Designed to recruit around 240 subjects with moderate-to-severe chronic plaque psoriasis, the trial will evaluate whether BI 695501 can be interchanged with Humira.

The trial will investigate the safety, immunogenicity, pharmacokinetics, efficacy and clinical outcomes in subjects administered continuously with Humira and in patients who will switch repeatedly between Humira and BI 695501.

"The initiation of this study reinforces our commitment to improving the lives of patients suffering from serious chronic or life-threatening diseases through biosimilars."

Boehringer Ingelheim Therapeutic Area Biosimilars senior vice-president and head Ivan Blanarik said: “We are pleased that the first patient has now been enrolled in VOLTAIRE-X, and look forward to continued recruitment and patient follow-up.

“The initiation of this study reinforces our commitment to improving the lives of patients suffering from serious chronic or life-threatening diseases through biosimilars.

“With biosimilars, we will have the opportunity to expand treatment options while at the same time providing value to the healthcare system.” 

According to FDA, a biosimilar can be substituted if it generates a clinical result similar to its reference product in any given patient.

In a previous Phase III trial, BI 695501 demonstrated clinical equivalence to Humira in rheumatoid arthritis patients.