Boehringer Ingelheim announced results from a Phase I study of its biosimilar candidate for adalimumab (AbbVie’s Humira®), that demonstrated pharmacokinetic bioequivalence with both the U.S.-licensed and EU-approved reference products.
These data were presented in a poster at the American Association of Pharmaceutical Scientists (AAPS) Annual Meeting.
Professor Klaus Dugi, Medical Director, Boehringer Ingelheim UK & Ireland said, “This is an important step towards our ultimate goal of providing new biosimilar therapeutic options to health care providers and patients.
“Boehringer Ingelheim is a pioneer in biotechnology with a long-standing history of more than 35 years; as a logical next step biosimilars are an important new area of focus for us.”
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 (40 mg/0.8mL), U.S.-licensed or EU-approved adalimumab
The study found that safety, tolerability, and immunogenicity were comparable among the treatment groups.
