Business Wire (11/10/2015)

Boehringer Ingelheim has completed enrollment for a Phase III trial of BI695501, a biosimilar candidate to adalimumab (Humira—AbbVie). A Phase I trial recently demonstrated pharmacokinetic bioequivalence with the approved reference products. The Phase III clinical trial is a randomized, double-blind, active comparator trial in patients diagnosed with moderate to severe rheumatoid arthritis and who are currently receiving methotrexate. Each study participant will be 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, at Boehringer Ingelheim.

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