Interchangeability Clinical Study Between Adalimumab, Biosimilar Candidate Enrolls First Patient
Study will compare the pharmacokinetics and clinical outcomes between Humira biosimilar and its reference product in the treatment of moderate-to-severe chronic plaque psoriasis.
The first patient has been enrolled in an interchangeability study between biosimilar BI 695501 and the reference product adalimumab (Humira), according to a press release.
VOLTAIRE-X is the first study to investigate an interchangeability designation for a biosimilar candidate of adalimumab.
It includes 240 patients with moderate-to-severe chronic plaque psoriasis. According to the release, the study findings are expected in the second half of 2019.
The study aims to compare the pharmacokinetics and clinical outcomes between patients who receive adalimumab continuously and those who switch repeatedly between adalimumab and BI 695501. It will also assess the biosimilar candidate’s safety, efficacy, and immunogenicity.
“We are pleased that the first patient has now been enrolled in VOLTAIRE-X, and look forward to continued recruitment and patient follow-up,” Ivan Blanarik, senior vice president and head of Therapeutic Area Biosimilars at Boehringer Ingelheim, said in the release. “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 health care system.”
Results from a phase 3 trial demonstrating clinical equivalence of BI 695501 to adalimumab in patients with rheumatoid arthritis was recently presented at the annual European Congress of Rheumatology.
The FDA and European Medicines Agency has accepted BI 695501 for regulatory review.