Boehringer Ingelheim's Biosimilar Candidate Demonstrated Pharmacokinetic Bioequivalence to Adalimumab

- 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®

- 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

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Boehringer Ingelheim Pharmaceuticals, Inc.

Oct 28, 2015, 08:30 ET

RIDGEFIELD, Conn. and ORLANDO, Fla., Oct. 28, 2015 /PRNewswire/ -- 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. 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.

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. Boehringer Ingelheim is committed to becoming a global leader in biosimilars and increasing the availability of high quality biologics.

About Boehringer Ingelheim Pharmaceuticals, Inc.
Boehringer Ingelheim Pharmaceuticals, Inc., based in Ridgefield, CT, is the largest U.S. subsidiary of Boehringer Ingelheim Corporation.

Boehringer Ingelheim is one of the world's 20 leading pharmaceutical companies. Headquartered in Ingelheim, Germany, the company operates globally with 146 affiliates and more than 47,000 employees. Since its founding in 1885, the family-owned company has been committed to researching, developing, manufacturing and marketing novel treatments for human and veterinary medicine.

Boehringer Ingelheim is committed to improving lives and providing valuable services and support to patients and families. BI's employees create and engage in programs that strengthen our communities. To learn more about how we make more health for more people, visit our Corporate Social Responsibility Report.

In 2014, Boehringer Ingelheim achieved net sales of about $16.96 billion dollars (13.3 billion euros). R&D expenditure corresponds to 19.9 percent of its net sales.

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SOURCE Boehringer Ingelheim Pharmaceuticals, Inc.