Sandoz proposed biosimilars adalimumab and infliximab accepted for regulatory review by the EMA

Biosimilar infliximab alone could potentially save the NHS £89 million.

Adalimumab and infliximab are the first and 5th most expensive medicines on the NHS by prescribing cost respectively,ii totalling a combined spend of approximately £594 million in 2015/16. The introduction of biosimilars for these medicines may contribute to a significant reduction in the NHS medicines bill, with biosimilar infliximab alone potentially contributing savings of £89 million. These savings offer the potential for reinvestment to improve patient care or access to future treatments.

Tim de Gavre, Country Head of Sandoz UK, said: “The filing acceptance of both adalimumab and infliximab biosimilar medicines by the EMA is a significant milestone for Sandoz. 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. Today’s news reinforces Sandoz’s leadership in the biosimilars field and strengthens our commitment to patient access and the research and development of biosimilar medicines.”

Sandoz is seeking approval of both medicines for use in all indications in line with their respective reference products. If approved, these medicines will be available for patients with conditions such as rheumatoid arthritis (RA) and inflammatory bowel disease, which affect approximately 400,000 and 240,000 patients in the UK respectively.

The EMA submissions include analytical, preclinical and clinical data packages across quality, efficacy, and safety which demonstrate biosimilarity of the proposed biosimilar medicines to the respective reference medicines. The biosimilar adalimumab submission includes clinical data from pharmacokinetic pharmacodynamic (PK/PD) studies and a Phase III confirmatory efficacy and safety study in patients with moderate to severe chronic plaque psoriasis. The biosimilar infliximab submission includes clinical data from a PK/PD study and a Phase III confirmatory efficacy and safety study in rheumatoid arthritis.