Boehringer Ingelheim Adalimumab Biosimilar Accepted for Review by FDA and EMA

Boehringer Ingelheim’s adalimumab biosimilar candidate to Humira, BI 695501, has been accepted for regulatory review by both the FDA and the European Medicines Agency (EMA).

The applications for FDA and EMA approvals are supported by top-line results from the completed Phase III study of BI 695501 that were announced in October 2016, which was conducted in patients with active rheumatoid arthritis (RA), according to Boehringer Ingelheim. [] The results of the study showed that BI 695501 met the clinical study efficacy end points to establish equivalence with Humira in patients with active RA and also met the secondary end points for the efficacy, safety, and immunogenicity of BI 695501 versus Humira.

The Phase III study was a randomized, double-blind, parallel arm, multiple dose, active comparator study in 645 patients diagnosed with moderate to severe active RA who were treated with methotrexate. Each participant was randomized to either BI 695501 or Humira every 2 weeks for 48 weeks. Efficacy was measured in patients with RA by ascertaining the proportion of patients with RA who met American College of Rheumatology 20 (ACR20) criteria at week 12 and week 24 compared with baseline.

If approved, BI 695501 can offer a high-quality, economically sustainable treatment option to patients with inflammatory diseases, said Martina Flammer, Vice President, Clinical Development and Medical Affairs, Specialty Care, at Boehringer Ingelheim, and would be a critical milestone for the company as it seeks to expand treatment options for patients with biosimilars.