Published : 8 years ago, on 01/06/2017

Sandoz, a Novartis division, and a pioneer and global leader in biosimilars, announced today that the European Medicines Agency (EMA) has accepted the Marketing Authorisation Applications for biosimilars to Humira^®* (adalimumab) and Remicade^®** (infliximab), both of which are used to treat immunological diseases. Biosimilars are biological medicines that have been developed to be highly similar and clinically equivalent to their reference product, but at a lower cost to the NHS.^[i] Today’s news comes shortly after two positive Committee for Medicinal Products for Human Use (CHMP) opinions for Sandoz biosimilars of etanercept and rituximab, reinforcing Sandoz’s immunology pipeline and the broader Novartis immunology portfolio.

Adalimumab and infliximab are the first and 5^th most expensive medicines on the NHS by prescribing cost respectively,ⁱⁱ totalling a combined spend of approximately £594 million in 2015/16.^[ii] 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.^ii,[iii] 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.^[iv],[v]

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.^[vi] The biosimilar infliximab submission includes clinical data from a PK/PD study and a Phase III confirmatory efficacy and safety study in rheumatoid arthritis.^[vii]

Sandoz is committed to increasing patient access to high-quality, life-enhancing biosimilars. It is a pioneer and global leader in biosimilars and currently markets three biosimilars worldwide.

[i] NHS England. What is a Biosimilar Medicine? 2015. Available at: https://www.england.nhs.uk/wp-content/uploads/2015/09/biosimilar-guide.pdf. Last accessed May 2017.

[ii] NHS Digital. Prescribing Costs in Hospitals and the Community. Available at: http://www.content.digital.nhs.uk/catalogue/PUB22302/hosp-pres-eng-201516-report.pdf. Last accessed May 2017.

[iii] Royal College of Physicians. National clinical audit report of biological therapies: UK inflammatory bowel disease (IBD) audit. 2016. Available at:https://www.rcplondon.ac.uk/projects/outputs/national-clinical-audit-biological-therapies-annual-report-2016. Last accessed May 2017.

[iv] Arthritis Research UK. State of Musculoskeletal Health 2017. Available at: http://www.arthritisresearchuk.org/arthritis-information/data-and-statistics/state-of-musculoskeletal-health.aspx. Last accessed May 2017.

[v] Rubin GP, Hungin AP, Kelly PJ, Ling J; Inflammatory Bowel Disease: epidemiology and management in an English general practice population. Aliment. Pharmacol. Ther. 2000; 14:1553-1559

[vi] Blauvelt A et al. A randomized, double-blind, multicenter study to compare the efficacy, safety, and immunogenicity of a proposed adalimumab biosimilar (GP2017) with originator adalimumab in patients with moderate-to-severe chronic plaque psoriasis. Poster #5224 presented at the 2017 American Academy of Dermatology (AAD) Annual Meeting, 3-7 March 2017.

[vii] Pfizer Inc. Pfizer Announces Positive Top-Line Results from REFLECTIONS B537-02 Study for PF-06438179 (infliximab-Pfizer) a Potential Biosimilar to Remicade® (infliximab). Available at: http://www.pfizer.com/news/press-release/press-release-detail/pfizer_announces_positive_top_line_results_from_reflections_b537_02_study_for_pf_06438179_infliximab_pfizer_a_potential_biosimilar_to_remicade_infliximab. Last accessed May 2017.