Boehringer Ingelheim commences new study of adalimumab biosimilar

Boehringer Ingelheim has announced the commencement of a new clinical study of its new adalimumab biosimilar candidate BI 695501.

The first patient has now been enrolled for VOLTAIRE-X, an interchangeability study that aims to demonstrate that BI 695501 is interchangeable with AbbVie's Humira, the branded drug upon which this biosimilar is based.

Pharmacokinetics and clinical outcomes will be compared between patients receiving Humira continuously and those who switch repeatedly between Humira and BI 695501. The study will also assess safety, immunogenicity and efficacy.

VOLTAIRE-X will enroll 240 patients with moderate to severe chronic plaque psoriasis, with results from the study expected in the second half of 2019.

Ivan Blanarik, senior vice-president and head of biosimilars at Boehringer Ingelheim, said: "The initiation of this study reinforces our commitment to improving the lives of patients suffering from serious chronic or life-threatening diseases through biosimilars."

This is the first study in the US to investigate an interchangeability designation for an adalimumab biosimilar candidate, with the findings of the trial set to support regulatory applications for the therapy.

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