Boehringer's Humira biosimilar compares well to brand product

Boehringer Ingelheim has announced data from the pivotal Phase III VOLTAIRE-RA study confirm that its adalimumab biosimilar candidate, BI 695501, has similar efficacy, safety and immunogenicity to AbbVie’s (NYSE: ABBV) mega-blockbuster Humira in patients with moderate-to-severe rheumatoid arthritis.

The results will be presented at the European Congress of Rheumatology (EULAR) in Madrid, Spain. These data confirm the clinical efficacy equivalence of BI 695501 to Humira, the German family-owned pharma major said. 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, head of global medical affairs biosimilars at Boehringer Ingelheim.