Another Humira biosimilar accepted for EMA and FDA regulatory review

18 January 2017

Boehringer Ingelheim is the latest to announce that its biosimilar to AbbVie’s (NYSE: ABBV) blockbuster drug Humira (adalimumab), BI 695501, has been accepted for regulatory review by the European Medicines Agency and the US Food and Drug Administration.

“We believe that if approved, BI 695501 can provide a valuable treatment option for the people affected by inflammatory diseases in the US and Europe,” said Ivan Blanarik, senior vice president and head of Therapeutic Area Biosimilars, at German family-owned 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,” he added.

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.

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