Biosimilars accepted for review by the EMA
The European Medicines Agency (EMA) has accepted for regulatory review the marketing authorisation applications for biosimilars to AbbVie’s Humira (adalimumab) and Janssen’s Remicade (infliximab) from Sandoz, a Novartis division focused on generic pharmaceuticals and biosimilars.
Both drugs are used to treat immunological diseases and Sandoz is seeking approval for the biosimilars for use in the exact same indications as their respective reference medicines.
“Patients with autoimmune diseases such as rheumatoid arthritis and inflammatory bowel disease rely on biologic medicines like adalimumab and infliximab to stay well, but unfortunately access to these essential medicines can be limited,” said Dr Mark Levick, PhD, global head of development, Biopharmaceuticals, Sandoz. “The EMA’s acceptance of our regulatory submissions for our biosimilar adalimumab and infliximab is a significant step towards improving patient access to these important biologic medicines, both of which are part of our steadily advancing pipeline.”
According to a press report from CPhI Online, these biosimilars could save the NHS vast amounts of money in medicines bills — infliximab alone offering the NHS a saving of £89 million.
“The filing acceptance of both adalimumab and infliximab biosimilar medicines by the EMA is a significant milestone for Sandoz,” remarked Tim de Gavre, country head of Sandoz in the CPhI Online report. “Biologics are an established class of medicines that have revolutionised treatment for patients with immunological diseases. If approved, biosimilar adalimumab and biosimilar infliximab may increase access to these important medicines, which currently on the NHS can be limited.”
Submissions for the EMA include analytical, preclinical and clinical data demonstrating the biosimilarity of the proposed treatments to the reference medicines. For adalimumab, Sandoz has included clinical data from pharmacokinetic studies and a Phase III confirmatory efficacy and safety study in patients with moderate to severe psoriasis. The Infliximab submission also includes clinical data from a pharmacokinetic study and a Phase III confirmatory efficacy and safety study in patients with rheumatoid arthritis.