Sandoz, a Novartis division and the global leader in biosimilars, announces results from the EQUIRA study. The phase III comparative safety and efficacy study shows that Sandoz biosimilar Erelzi (etanercept-szzs) matches the reference medicine Enbrel, in terms of efficacy and safety profile in patients with moderate-to-severe rheumatoid arthritis (RA) and inadequate response to disease-modifying anti-rheumatic drugs (DMARDs) over 24 weeks. The results were presented at the American College of Rheumatology (ACR) Annual Meeting in San Diego, US.
“Approximately 1.3 million adults in the US are diagnosed with rheumatoid arthritis and its impact on the patient and the healthcare system is significant since rheumatic conditions are amongst the leading cause of disability in adults” said Mark Levick, MD PhD, Global Head of Development, Biopharmaceuticals, Sandoz. “These study results confirm findings from our initial development program demonstrating that Erelzi has the potential to expand access for patients with immunological diseases, including rheumatoid arthritis, and offers an important new biologic treatment option to healthcare professionals and payors.”
The EQUIRA study is a randomized, double-blind phase III confirmatory efficacy and safety study, which involved 326 patients with moderate-to-severe RA and an inadequate response to DMARDs. The primary endpoint was change from baseline in DAS28-CRP at week 24.
The study demonstrated that Erelzi matches the reference medicine in terms of efficacy and safety profile as measured by the mean change from baseline in DAS28-CRP, the ACR 20/50/70 response rates, and reported treatment-emergent adverse events.
Erelzi was approved by the US Food and Drug Administration (FDA) in August 2016 and the European Commission (EC) in July 2017 for use in all indications of the reference medicine at the time of approval. These approvals were based on a comprehensive development program generating analytical, preclinical, and clinical data, including pharmacokinetic (PK) studies and a confirmatory clinical trial. Health Canada granted Erelzi a Notice of Compliance in April 2017, and the product has been launched. Erelzi received positive reimbursement recommendation from the Canadian Common Drug Review.
Sandoz is committed to increasing patient access to high-quality biosimilar medicines. As the global leader in biosimilar medicines, Sandoz has five biosimilar medicines currently marketed worldwide, as well as a leading global pipeline. Sandoz is well positioned to continue leading the biosimilar industry based on its experience and capabilities in development, manufacturing and commercialization. As a division of Novartis, the first global healthcare company to establish a leading position in both innovative and off-patent medicines, Sandoz benefits strongly from this unique blend of experience and expertise in many different market environments.