Boehringer Ingelheim biosimilar candidate to Humira® accepted for EMA and FDA regulatory review
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
This press release is issued from our Corporate Headquarters in Ingelheim, Germany and is intended to provide information about our global business. Please be aware that information relating to the approval status and labels of approved products may vary from country to country, and a country-specific press release on this topic may have been issued in the countries where we do business.
Media + PR
Phone: +49 6132 – 77 2356
Fax: +49 6132 – 77 6601
Information om Business Wire
101 California Street, 20th Floor
CA 94111 San Francisco
Følg pressemeddelelser fra Business Wire
Ved at skrive dig op her, vil du modtage pressemeddelelser på mail når de udsendes. Indtast din mail og følg instruktionerne. Det er ligeså let at melde sig fra igen.
Flere pressemeddelelser fra Business Wire
IPSEN19.9.2017 18:03 | pressemeddelelse
Ipsen Receives Approval from European Commission for Xermelo® (Telotristat Ethyl) for the Treatment of Carcinoid Syndrome Diarrhea in Patients Inadequately Controlled by Somatostatin Analogue Therapy
CA-PATIENT-SAFETY-MVMNT19.9.2017 17:02 | pressemeddelelse
6th Annual World Patient Safety, Science & Technology Summit to Be Held in London, England
MA-VERTEX19.9.2017 16:52 | pressemeddelelse
Vertex Announces Upcoming Presentations of Data at 2017 North American Cystic Fibrosis Conference
DELTICOM-AG19.9.2017 15:59 | pressemeddelelse
Biker Summer 2017 campaign: Last Chance to Win Great Prizes from Moto-tyres.co.uk
CA-ANDERSEN-TAX19.9.2017 15:32 | pressemeddelelse
Andersen Global Expands into Uruguay
HORIZON-PETROLEUM19.9.2017 15:07 | pressemeddelelse
Horizon Petroleum Enters into Definitive Agreements to Acquire Concessions in Poland
I vores nyhedsrum kan du læse alle vores pressemeddelelser, tilgå materiale i form af billeder og dokumenter, og finde vores kontaktoplysninger.Besøg vores nyhedsrum