Earlier this month, the journal of Expert Opinion on Drug Delivery published results from a clinical study of BI 695501, an adalimumab biosimilar, using an autoinjector (AI). BI 695501 is a self-injectable adalimumab biosimilar that according to the publication has “demonstrated PK bioequivalence and similar clinical efficacy, safety, and immunogenicity with its reference product, Humira®.” The Phase II, 7-week, open-label, single-arm, interventional clinical trial (NCT02606903) was sponsored by Boehringer Ingelheim and designed to evaluate the usability of BI 695501 in an AI by Rheumatoid Arthritis (RA) patients. Efficacy was not evaluated as part of this trial but safety data was collected and reported. No new safety information was identified. The publication concludes that following training by study site personnel, “almost all patients with moderately to severely active RA without prior experience of self-injection with AIs were able to successfully self-administer BI 695501[.]”
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