RIDGEFIELD, CT, USA I November 10, 2015 I Boehringer Ingelheim today announced it has completed enrollment for the pivotal Phase III trial (NCT02137226) of BI695501, a biosimilar candidate to adalimumab (AbbVie’s Humira®). This announcement was made following recent results from a Phase I trial that demonstrated pharmacokinetic bioequivalence with both the U.S.-licensed and EU-approved reference products. These Phase I data for BI695501 were discussed today at the American College of Rheumatology / Association of Rheumatology Health Professionals (ACR/ARHP) Annual Meeting in San Francisco (Abstract 2727).
The Phase III clinical trial is a randomized, double-blind, parallel arm, multiple dose, active comparator trial in patients who have been diagnosed with moderate to severe rheumatoid arthritis and are currently being treated with methotrexate. Each participant is randomized to receive either BI695501 or the U.S.-licensed reference product every two weeks for 48 weeks.
“We are excited to reach this important milestone for BI695501, which brings us closer to our goal of delivering new options to patients through our investigational biosimilars portfolio,” said Peter Piliero, MD, vice president, Clinical Development and Medical Affairs, Boehringer Ingelheim Pharmaceuticals, Inc. “Our long-term commitment is to become a global leader in biosimilars, thereby supporting access to biologic medicines around the world.”
Results for the completed Phase I study for adalimumab were announced on October 28.
About Boehringer Ingelheim in Biologics
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 brought more than 20 biologic medicines to patients around the world. Boehringer Ingelheim is committed to becoming a global leader in biosimilars and increasing the availability of high quality biologics.
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 146 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 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 2014, Boehringer Ingelheim achieved net sales of about $16.96 billion dollars (13.3 billion euros). R&D expenditure corresponds to 19.9 percent of its net sales.
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To learn about recent news for Boehringer Ingelheim’s biosimilar candidate to adalimumab, please visit http://us.boehringer-ingelheim.com/news_events/press_releases/press_release_archive/2015/11-10-2015-boehringer-ingelheim-announces-completed-enrollment-phase-iii-clinical-trial-biosimilar-candidate-adalimumab.html.
SOURCE: Boehringer Ingelheim
Published on Wednesday, 11 November 2015