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news.Boehringer Ingelheim’s adalimumab biosimilar candidate has demonstrated similar efficacy and safety profile to AbbVie’s Humira in pivotal phase III study in patients with active rheumatoid arthritis (RA).
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The phase III randomized, double-blind, parallel arm, multiple dose, active comparator study also met secondary endpoints.
The study included 645 patients diagnosed with moderate to severe active RA who were treated with methotrexate.
Each participant was randomized to receive either BI 695501 or Humira every two weeks for 48 weeks.
The trial’s primary objective was to establish statistical equivalence in efficacy between BI 695501 and Humira in patients with active RA as measured by the proportion of patients meeting American College of Rheumatology 20 criteria at week 12 and at week 24 compared to baseline.
The secondary objectives were to compare other efficacy parameters (DAS28), safety and immunogenicity of BI 695501 and Humira.
Boehringer Ingelheim said it will present the trial’s results at future medical congresses.
Boehringer Ingelheim Pharmaceuticals vice president of clinical development and medical affairs specialty care Martina Flammer said: “This milestone paves the way for submitting BI 695501 for regulatory approval in key markets such as the USA and Europe.
“With our focus on BI 695501 and other biosimilar candidates, we recognize biosimilars as playing an increasing role in providing patients and doctors with high quality therapeutic options while contributing to the long term sustainability of healthcare systems.”
Apart from BI 695501, Boehringer is also developing BI 695502, bevacizumab biosimilar candidate to Genentech’s Avastin.