Advertise With UsAdvertise on our extensive network of industry websites and newsletters.
Get the PBR newsletterSign up to our free email to get all the latest PBR
news.Boehringer Ingelheim's BI 695501, the adalimumab biosimilar candidate to Humira, has been accepted for regulatory review by the European Medicines Agency (EMA) and the US Food and Drug Administration (FDA).
Subscribe to our email newsletter
Boehringer Ingelheim Therapeutic Area Biosimilars senior vice president and head Ivan Blanarik said: “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.
“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.
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 approx. 36.3 million people in Europe.
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.