Manufacturer Seeks Interchangeability Designation for Humira Biosimilar

Boehringer Ingelheim recently announced that the first patient has been enrolled in the VOLTAITE-X study, which is assessing the interchangeability of an adalimumab (Humira) candidate biosimilar in the treatment of chronic plaque psoriasis, according to a press release.

Interchangeability is an FDA designation that means a biosimilar has no clinically meaningful differences from the reference product. Interchangeable biosimilars may be substituted in place of a biologic drug without prescriber intervention.

The goal of the clinical trial is to demonstrate that BI 695501 is interchangeable with adalimumab 40-mg/0.8-mL, according to the release. Boehringer reports that this is the first study to explore the interchangeability of an adalimumab biosimilar candidate.

VOLTAIRE-X will compare the pharmacokinetics and outcomes among patients treated with continuous adalimumab compared with those who switch between adalimumab and BI 698801, according to the release. The investigators will also look at the safety, immunogenicity, and efficacy of the biosimilar candidate.

Boehringer expects to enroll 240 patients with moderate-to-severe chronic plaque psoriasis. They project that the results will be available in 2019, according to the release.

Additionally, results from a phase 3 clinical trial show equivalence between BI 695501 and adalimumab in patients with rheumatoid arthritis.

Thus far, BI 695501 has been accepted for review by the FDA and the European Medicines Agency.

“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.”