Study looks at interchangeability between adalimumab biosimilar candidate and Humira

Boehringer Ingelheim announced that patient enrollment has begun for its study to demonstrate that BI 695501, its adalimumab biosimilar candidate, is interchangeable with the U.S.-marketed formulation of Humira 40 mg/0.8 mL.

The pharmacokinetics and clinical outcomes will be compared between patients with moderate-to-severe chronic plaque psoriasis receiving Humira (adalimumab, AbbVie) continuously and those who switch repeatedly between adalimumab and BI 695501, according to a news release. Safety, immunogenicity and efficacy also will be measured in the study.

There will be 240 patients enrolled in the study, with results expected in the second half of 2019, Boehringer Ingelheim reported.

The FDA defines an interchangeable biologic as a biosimilar that produces the same clinical result as its reference product in any given patient, according to the release.

Interchangeability is an FDA designation that means a biosimilar may be substituted by a pharmacist for the reference product without the intervention of the health care provider who wrote the prescription, subject to individual state law, Boehringer Ingelheim reported.

“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, stated in the release.

The FDA and the European Medicines Agency have accepted BI 695501 for regulatory review, according to the release.

Phase 3 results demonstrating clinical equivalence of BI 695501 to Humira in patients with rheumatoid arthritis were recently presented at the annual European Congress of Rheumatology, Boehringer Ingelheim reported.

Reference: www.boehringer-ingelheim.us