Phase III clinical trial for BI695501, a biosimilar candidate for AbbVie’s Humira®, fully enrolled
Recently announced Phase I trial results show pharmacokinetic bioequivalence of BI695501 to U.S.-licensed and EU-approved adalimumab reference products1A
First scientific data presentation for a Boehringer Ingelheim biosimilar compound at the ACR/ARHP Annual Meeting
Ingelheim, Germany, November 10, 2015 — 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.1A 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.
The Phase III clinical trial is a randomized, double-blind, parallel arm, multiple dose, active comparator trial in patients2A who have been diagnosed with moderate to severe rheumatoid arthritis and are currently being treated with methotrexate.2B 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 Sandeep Athalye, MD, Vice President and Head, Clinical Development and Medical Affairs Biosimilars, Boehringer Ingelheim. “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.3 Boehringer Ingelheim is committed to becoming a global leader in biosimilars and increasing the availability of high quality biologics.
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.4 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 worldwide5 and 1.6 million people in the United States.6,7 It can develop at any time during adulthood, but it usually occurs between 40 and 70 years of age.