INGELHEIM, Germany - Wednesday, October 26th 2016 [ME NewsWire]
Phase III study established equivalence in efficacy and similar safety profile between BI 695501 and Humira® (adalimumab) in patients with active rheumatoid arthritis (RA)
Results pave the way for submitting BI 695501 for regulatory approval in key markets
(BUSINESS WIRE)-- 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 study1 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.2
The secondary objectives of this clinical study were to compare other efficacy parameters (DAS28)3, safety and immunogenicity of BI 695501 and Humira®.
Results from this clinical study will be published and presented at future medical congresses.
This press release is issued from our Corporate Headquarters in Ingelheim, Germany and is intended to provide information about our global business. Please be aware that information relating to the approval status and labels of approved products may vary from country to country, and a country-specific press release on this topic may have been issued in the countries where we do business.
For references and notes to editors, please visit: http://www.boehringer-ingelheim.com/press-release/boehringer-ingelheim-s-adalimumab-biosimilar-candidate-shows-similar-efficacy-and
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