Last week, Boehringer Ingelheim announced that BI 695501, a proposed biosimilar of Humira (adalimumab), met the primary efficacy endpoint in a pivotal Phase III study comparing BI 695501 to Humira for treatment of patients with rheumatoid arthritis. The company says that the results of the study show that BI 695501 has similar safety and efficacy to Humira, and that the results “pave the way for submitting BI 695501 for regulatory approval in key markets such as the USA and Europe.”
Stay tuned to Big Molecule Watch for further developments.