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Our data demonstrate that BI695501 and its reference product Humira (adalimumab) are comparable in terms of safety, efficacy and immunogenicity, Karsten Kissel, Head of Global Medical Affairs Biosimilars at Boehringer Ingelheim, told European Biotechnology. Headline results had been already announced in October 2016. At EULAR 2017 in Madrid, however, detailed results were presented for the first time.
The co-primary endpoint, ACR20 after 12 and 24 weeks of biweekly subcutaneous administration of a 40 mg/kg dose of BI695501 + methothrexate vs Humira + methothrexate was met (12 months: 67% vs. 61.1%, 24 months: 69% vs 64.5%) in the VOLTAIRE-RA…