“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
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For references and notes to editors, please visit:
http://www.boehringer-ingelheim.com/press-release/biosimilar-candidate-shows-clinical-equivalence-humira