Boehringer Ingelheim has announced the 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
About Boehringer Ingelheim in Biologics and Biosimilars
Boehringer Ingelheim is one of the largest producers of biologic medicines in the world. As a pioneer in biologics with more than 35 years of experience, the company has manufactured more than 25 biologic medicines for global markets. This includes monoclonal antibodies in oncology and immunology, interferons, and other targeted medicines that are routinely used to treat many patients across a broad range of therapeutic areas. Boehringer Ingelheim further builds on its commitment to oncology and immunology to develop biosimilars as high quality, safe, and effective treatment options to patients with cancer and autoimmune diseases.
Boehringer Ingelheim currently has two biosimilar monoclonal antibodies in late stage development: BI 695501, adalimumab biosimilar candidate to Humira® and BI 695502, bevacizumab biosimilar candidate to Avastin®.