Boehringer Ingelheim announced the first patient has been enrolled into its VOLTAIRE-X interchangeability study. The goal of the study is 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.
"We are pleased that the first patient has now been enrolled in VOLTAIRE-X, and look forward to continued recruitment and patient follow-up," said Ivan Blanarik, Senior Vice President and Head of Therapeutic Area Biosimilars at Boehringer Ingelheim. "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."
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.
As per the U.S. Food and Drug Administration, an interchangeable biologic is a biosimilar that produces the same clinical result as its reference product in any given patient. Interchangeability is a designation by the FDA that means a biosimilar may be substituted by a pharmacist for the reference product without the intervention of the healthcare provider who wrote the prescription, subject to individual state law. More than half of the U.S. have either passed or are considering state laws regarding automatic substitution of biologics.
Plaque psoriasis is an autoimmune disease characterized by dry, red skin lesions which are covered in silver scales. Accounting for approximately 80 percent of cases it is the most common form of psoriasis. Common sites of the disease include elbows, knees, scalp and lower back, but affected areas can appear anywhere on the body.