This announcement was made following recent results from a Phase I trial that demonstrated pharmacokinetic bioequivalence with both the US-licensed and EU-approved reference products. These Phase I data for BI695501 were discussed 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 US-licensed reference product every 2 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.”
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.