Boehringer Ingelheim Statement: Favorable Ruling on Humira® Patent Challenge from U.S. Patent and Trademark Office

The U.S. Patent and Trademark Office (PTO) has ruled in favor of Boehringer Ingelheim’s petitions for inter partes reviews (IPRs) against U.S. Patent 8,889,135 for AbbVie’s Humira®* (adalimumab). This decision invalidates all claims of the patent as they relate to a specific dosing regimen for Humira® for the treatment of rheumatoid arthritis.

We are pleased by this favorable decision from the PTO, as it represents an important step towards our goal of providing an adalimumab biosimilar to the many patients who rely on this medication. 

Boehringer Ingelheim currently has two biosimilar monoclonal antibodies in late stage development: BI 695501, adalimumab biosimilar candidate to Humira® and BI 695502, bevacizumab biosimilar candidate to Avastin®.* All public information on our clinical trials is available on: http://clinicaltrials.gov/. BI 695501 has been accepted for regulatory review by the European Medicines Agency and the U.S Food and Drug Administration and more information be found here.

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 manufactured more than 25 biologic medicines for global markets. This includes monoclonal antibodies in oncology and immunology, interferons, and other targeted medicines that are routinely used to treat many patients across a broad range of therapeutic areas. Boehringer Ingelheim further builds on its commitment to oncology and immunology to develop biosimilars as high quality, safe, and effective treatment options to patients with cancer and autoimmune diseases.

*Humira® is a registered trademark of AbbVie, Inc. and Avastin® is a registered trademark of Genentech, Inc. (USA).

Media Contact:
Susan Holz
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Phone: (203) 798-4265
E-mail: susan.holz@boehringer-ingelheim.com