Date: 2015-11-06
Type of
information: Presentation of results at a congress
phase: 1
Announcement: presentation of results at the American Association of Pharmaceutical Scientists (AAPS) Annual Meeting
Company: Boehringer Ingelheim (Germany)
Product: BI 695501 (biosimilar version of Humira® (adalimumab))
Action
mechanism: biosimilar/monoclonal antibody/TNF alpha inhibitor
Disease:
Therapeutic
area: Autoimmune diseases – Dermatological diseases - Inflammatory diseases - Rheumatic diseases
Country: Belgium, New Zealand
Trial
details: This randomized, double-blind, single dose, parallel-arm, active comparator clinical phase I study investigates pharmacokinetics, tolerability and safety of BI 695501 in healthy subjects. (NCT02045979)
Latest
news:
- • On October 28, 2015, Boehringer Ingelheim announced results from a Phase I study of its biosimilar candidate (BI695501) for adalimumab (AbbVie’s Humira®), that demonstrated pharmacokinetic bioequivalence with both the U.S.-licensed and EU-approved reference products.1A These data were presented in a poster at the American Association of Pharmaceutical Scientists (AAPS) Annual Meeting. The Phase I trial was a randomized, double-blind, single dose, parallel-arm study in healthy individuals. 327 healthy males between the ages of 18 and 55 participated. Each participant was randomized to receive one subcutaneous dose (40mg/0.8mL) of either BI695501, U.S.-licensed or EU-approved adalimumab. The study found that safety, tolerability and immunogenicity were comparable among the treatment groups.
Is
general: Yes
