Boehringer Ingelheim (BI, Ingelheim, Germany) has announced that the first patient in the VOLTAIRE-X interchangeability study has been enrolled. The aim of the study is to demonstrate that BI’s adalimumab biosimilar candidate, BI 695501, is interchangeable with the AbbVie Biotechnology Ltd. (IL, USA) formulation Humira®. This is the first instance in the US where the interchangeability for an adalimumab biosimilar has been investigated.
The VOLTAIRE-X study consists of 240 patients with moderate to severe cases of plaque psoriasis, a chronic autoimmune disease that is characterized by dry red skin lesions covered in silver scales.
During the study, the pharmacokinetic and clinical outcomes will be assessed in patients who are receiving Humira continuously and those who switch repeatedly between BI 695501 and Humira. In addition, the study will also investigate the safety, immunogenicity and the efficiency of BI 695501. The results of the study are due to be ready for release in the second half of 2019.
“We are pleased that the first patient has now been enrolled in VOLTAIRE-X, and look forward to continued recruitment and patient follow-up,” commented Ivan Blanarik, Senior Vice President and Head of Therapeutic Area Biosimilars, BI.
“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.”
At present, BI 695501 is currently under review by the European Medicines Agency and the US FDA. B1 695501 has also been demonstrated as a clinical equivalence to Humira in a phase III study for patients with rheumatoid arthritis.