- Results pave the way for submitting BI 695501 for regulatory approval in key markets
RIDGEFIELD, Conn., Oct. 26, 2016 /PRNewswire/ -- 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 Martina Flammer, MD, Vice President Clinical Development and Medical Affairs Specialty Care, Boehringer Ingelheim Pharmaceuticals, Inc. "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.
About Boehringer Ingelheim in Biologics and Biosimilars
Boehringer Ingelheim is one of the largest producers of biologic medicines in the world. As a pioneer in biologics with more than 35 years of experience, the company has manufactured more than 25 biologic medicines for global markets. This includes monoclonal antibodies in oncology and immunology, interferons, and other targeted medicines that are routinely used to treat many patients across a broad range of therapeutic areas. Boehringer Ingelheim further builds on its commitment to oncology and immunology to develop biosimilars as high quality, safe, and effective treatment options to patients with cancer and autoimmune diseases.
Boehringer Ingelheim currently has two biosimilar monoclonal antibodies in late stage clinical development: BI 695501, adalimumab biosimilar candidate to Humira® and BI 695502, bevacizumab biosimilar candidate to Avastin®*. All public information on our clinical trials is available on: http://clinicaltrials.gov/
*Humira® is a registered trademark of AbbVie, Inc. and Avastin® is a registered trademark of Genentech, Inc. (USA).
About Rheumatoid Arthritis
Rheumatoid Arthritis (RA) is a chronic inflammatory autoimmune disease affecting synovial joint lining; causing pain, stiffness, swelling and limited motion and function of joints. In many patients, the progressive destruction of joints may ultimately result in disability. Three times as many women are affected by RA compared to men. RA affects approximately 23.7 million people worldwide and 1.6 million people in the United States. It can develop at any time during adulthood, but it usually occurs between 40 and 70 years of age.
About Boehringer Ingelheim Pharmaceuticals, Inc.
Boehringer Ingelheim Pharmaceuticals, Inc., based in Ridgefield, CT, is the largest U.S. subsidiary of Boehringer Ingelheim Corporation.
Boehringer Ingelheim is one of the world's 20 leading pharmaceutical companies. Headquartered in Ingelheim, Germany, the company operates globally with 145 affiliates and more than 47,000 employees. Since its founding in 1885, the family-owned company has been committed to researching, developing, manufacturing and marketing novel treatments for human and veterinary medicine.
Boehringer Ingelheim is committed to improving lives and providing valuable services and support to patients and their families. Our employees create and engage in programs that strengthen our communities. To learn more about how we make more health for more people, visit our Corporate Social Responsibility Report.
In 2015, Boehringer Ingelheim achieved net sales of about $15.8 billion (14.8 billion euros). R&D expenditure corresponds to 20.3 percent of its net sales.
For more information please visit www.us.boehringer-ingelheim.com, or follow us on Twitter @BoehringerUS.
SOURCE Boehringer Ingelheim
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