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Boehringer Ingelheim's Biosimilar Candidate Demonstrated Pharmacokinetic Bioequivalence to Adalimumab
Business Wire (10/28/2015)
A Phase I study of Boehringer Ingelheim's biosimilar candidate for adalimumab (Humira—AbbVie) demonstrated pharmacokinetic bioequivalence with both the U.S.-licensed and E.U.-approved reference products. The Phase I trial included 327 healthy males aged 18-55 years. Each participant was randomized to receive one subcutaneous dose (40mg/0.8mL) of either the biosimilar candidate, BI695501, or the U.S.-licensed or EU-approved adalimumab. Safety, tolerability, and immunogenicity were all found to be comparable among the treatment groups. The study results were presented at the American Association of Pharmaceutical Scientists Annual Meeting.
Abstract News © 2015 INFORMATION, INC.
