Boehringer Ingelheim biosimilar candidate to Humira® accepted for EMA and FDA regulatory review

• BI 695501 EMA and FDA applications are first biosimilar regulatory filings for Boehringer Ingelheim • Applications are supported by a comprehensive data package comprised of analytical, pre-clinical & clinical development studies

INGELHEIM, Germany -- (BUSINESS WIRE) --

Boehringer Ingelheim announced today that BI 695501, its adalimumab biosimilar candidate to Humira^®*, has been accepted for regulatory review by the European Medicines Agency (EMA) and the U.S Food and Drug Administration (FDA).

“We believe that if approved, BI 695501 can provide a valuable treatment option for the people affected by inflammatory diseases in the U.S. and Europe,” said Ivan Blanarik, Senior Vice President and Head of Therapeutic Area Biosimilars, Boehringer Ingelheim. “The acceptance of our first biosimilar regulatory filings by the FDA and EMA is an important milestone towards offering a high-quality treatment choice to patients and physicians while contributing to the sustainability of healthcare systems.”

Boehringer Ingelheim is seeking approval for BI 695501 as a biosimilar to Humira® in the European Union and the United States. Adalimumab is a monoclonal antibody that blocks TNF-α, an important mediator of inflammation in the human body.¹ Adalimumab is approved as a biologic medicine under the brand name Humira^® in many countries for the treatment of multiple chronic inflammatory diseases, such as rheumatoid arthritis, inflammatory bowel disease, and psoriasis. These disorders collectively affect the lives of 5-10% of the world population² including 23.5 million people in the U.S.³ and approx. 36.3 million people in Europe.⁴

Top-line results from the completed Phase III study for BI 695501 in patients with active rheumatoid arthritis (RA) were announced on October 26, 2016.

For references and notes to editors, please visit http://www.boehringer-ingelheim.com/press-release/boehringer-ingelheim-biosimilar-candidate-humira-accepted-ema-and-fda-regulatory

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