Boehringer Ingelheim Biosimilar Candidate to Humira® Accepted for EMA and FDA Regulatory Review

Boehringer Ingelheim announced 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).

"The acceptance of our regulatory filings by the FDA and EMA is a critical milestone as we explore innovative ways for biosimilars to expand overall treatment options and seek to improve the lives of patients with chronic and life-threatening diseases," said Martina Flammer, Vice President, Clinical Development and Medical Affairs, Specialty Care, Boehringer Ingelheim Pharmaceuticals, Inc. "If approved, we believe BI 695501 can offer a high quality, economically sustainable treatment option to patients with inflammatory diseases in the U.S."

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. 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 population including 23.5 million people in the U.S. and approximately 36.3 million people in Europe.

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