Boehringer Ingelheim has announced results from a Phase I study (NCT02045979) 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. These data were presented in a poster at the American Association of Pharmaceutical Scientists (AAPS) Annual Meeting.
"This is an important step towards our ultimate goal of providing new biosimilar therapeutic options to health care providers and patients," said Peter Piliero, MD, vice president, Clinical Development and Medical Affairs, Boehringer Ingelheim Pharmaceuticals, Inc. "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 (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.