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.

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