Boehringer Ingelheim's adalimumab biosimilar candidate shows promise

Phase III study established equivalence in efficacy and similar safety profile between BI 695501 and Humira (adalimumab) in patients with active rheumatoid arthritis.

"This milestone paves the way for submitting BI 695501 for regulatory approval in key markets such as the US and Europe," said Martina Flammer, MD, Vice President Clinical Development and Medical Affairs Specialty Care, Boehringer Ingelheim Pharmaceuticals. "With our focus on BI 695501 and other biosimilar candidates, we recognize biosimilars as playing an increasing role in providing patients and doctors with high quality therapeutic options while contributing to the long term sustainability of healthcare systems."

This Phase III clinical study was a randomized, double-blind, parallel arm, multiple dose, active comparator study in 645 patients diagnosed with moderate to severe active rheumatoid arthritis who were treated with methotrexate. Each participant was randomized to receive either BI 695501 or Humira every 2 weeks for 48 weeks. The primary objective of this clinical study was to establish statistical equivalence in efficacy between BI 695501 and Humira in patients with active RA as measured by the proportion of patients meeting ACR20 (American College of Rheumatology 20) criteria at Week 12 and at Week 24 compared to baseline.

The secondary objectives of this clinical study were to compare other efficacy parameters (DAS28), safety and immunogenicity of BI 695501 and Humira.