Orlando/Florida–(BUSINESS WIRE)– 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
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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