- Phase I trial evaluated pharmacokinetic and safety similarity of Boehringer Ingelheim’s adalimumab compound to both U.S.-licensed and EU-approved reference products, AbbVie’s Humira®1A
- Phase I clinical trial results for Boehringer Ingelheim’s adalimumab compound shared at AAPS Annual Meeting
- First scientific data presentation for a Boehringer Ingelheim biosimilar compound at the AAPS Annual Meeting
ORLANDO, FL, USA I October 28, 2015 I Boehringer Ingelheim today 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.1A 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 Sandeep Athalye, MD, Vice President and Head, Clinical Development and Medical Affairs Biosimilars, Boehringer Ingelheim. “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:1B
- 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 1C
The study found that safety, tolerability and immunogenicity were comparable among the treatment groups.1D
About Boehringer Ingelheim in Biologics
Boehringer Ingelheim is one of the largest producers of biologic medicines in the world. As a pioneer in biologics with more than 35 years of experience, the company has brought more than 20 biologic medicines to patients around the world.1 Boehringer Ingelheim is committed to becoming a global leader in biosimilars and increasing the availability of high quality biologics.
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