Boehringer Ingelheim today announced top-line results from the pivotal Phase III clinical study of BI 695501, a biosimilar candidate to U.S.-licensed Humira and EU approved Humira (adalimumab). BI 695501 met the clinical study primary efficacy endpoint to establish equivalence with Humira in patients with active rheumatoid arthritis (RA). The secondary endpoints for efficacy, safety and immunogenicity of BI 695501 vs. Humira, were also met.
“This milestone paves the way for submitting BI 695501 for regulatory approval in key markets such as the USA and Europe”, said Sandeep Athalye, MD, Vice President and Head, Clinical Development and Medical Affairs Biosimilars, Boehringer Ingelheim. ”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.”
This Phase III clinical study was a randomized, double-blind, parallel arm, multiple dose, active comparator study in 645 patients diagnosed with moderate to severe active rheumatoid arthritis who were treated with methotrexate. Each participant was randomized to receive either BI 695501 or Humira every two weeks for 48 weeks. The primary objective of this clinical study 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 ACR20 (American College of Rheumatology 20) criteria at Week 12 and at Week 24 compared to baseline.
The secondary objectives of this clinical study were to compare other efficacy parameters (DAS28), safety and immunogenicity of BI 695501 and Humira.
Results from this clinical study will be published and presented at future medical congresses.
Filed Under: Drug Discovery