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Boehringer Ingelheim today announced it has completed enrollment for the pivotal Phase III trial 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 at the American College of Rheumatology / Association of Rheumatology Health Professionals (ACR/ARHP) Annual Meeting in San Francisco.
Sandeep Athalye, MD, Vice President and Head, Clinical Development and Medical Affairs Biosimilars, Boehringer Ingelheim
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 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.”
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