Saturday, October 31, 2015

Boehringer Ingelheim’s Biosimilar Candidate Demonstrated Pharmacokinetic Bioequivalence to Adalimumab

Orlando/Florida - Wednesday, October 28th 2015 [ME NewsWire]

    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

(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

    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.

Intended audiences:

This press release is issued from our Corporate Headquarters in Ingelheim, Germany and is intended to provide information about our global business. Please be aware that information relating to the approval status and labels of approved products may vary from country to country, and a country-specific press release on this topic may have been issued in the countries where we do business.

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Boehringer Ingelheim

Corporate Communications

Media + PR

Matthias Kagerbauer

Phone: +49 6132 – 77 2356

Fax: +49 6132 – 77 6601



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