● Pivotal Phase III study results for biosimilar candidate BI 695501 will be presented for the first time at the Annual European Congress of Rheumatology (EULAR 2017)
● Phase III results complete the total body of evidence required to demonstrate biosimilarity to HUMIRA®
● BI 695501 currently under review by regulatory authorities
INGELHEIM, Germany & MADRID-Wednesday, June 14th 2017 [ ME NewsWire ]
(BUSINESS WIRE)-- Boehringer Ingelheim announced today results from the pivotal Phase III VOLTAIRE®-RA1 study, confirming that its adalimumab biosimilar candidate BI 695501 and HUMIRA®* have similar efficacy, safety and immunogenicity in patients with moderately-to-severely active rheumatoid arthritis. The 24 week results will be presented at the Annual European Congress of Rheumatology (EULAR 2017) in Madrid.
These data confirm the clinical efficacy equivalence of BI 695501 to HUMIRA®. The safety and immunogenicity data in the study were also similar between BI 695501 and HUMIRA®.
“The result that Boehringer Ingelheim’s adalimumab biosimilar candidate delivers the same clinical benefits and safety profile as HUMIRA® is great news for patients and physicians. If approved by regulatory authorities it will increase the treatment options for patients with autoimmune diseases, while contributing to the long-term sustainability of healthcare systems,” said Karsten Kissel, MD, Head of Global Medical Affairs Biosimilars at Boehringer Ingelheim. “These data, which complete our biosimilarity assessment, are currently under review by regulatory authorities along with an extensive package of non-clinical and clinical data that make up the total body of evidence required to register a biosimilar.”
In the VOLTAIRE®-RA1 study 645 patients aged between 18 and 80 years old with moderate-to-severely active rheumatoid arthritis on stable treatment with methotrexate were randomised to receive HUMIRA® or BI 695501 at 40 mg every two weeks for 48 weeks. The co-primary endpoints, which measured the proportion of patients achieving an ACR20** (American College of Rheumatology 20) improvement at weeks 12 and 24, were met. The one year results will be presented at a future medical congress.
Boehringer Ingelheim also announced data from the VOLTAIRE-AI2 study at EULAR 2017, demonstrating pharmacokinetic similarity of BI 695501’s pre-filled syringe and auto-injector presentations.
HUMIRA® (Adalimumab) is an approved biologic medicine 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 population3 including 23.5 million people in the U.S.4 and approx. 36.3 million people in Europe.5
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.
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