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SANDOZ PROPOSED BIOSIMILAR ADALIMUMAB MATCHES REFERENCE BIOLOGIC IN TERMS OF EFFICACY AND SAFETY IN LONG-TERM STUDY

  • 51-week clinical study compared Sandoz proposed biosimilaradalimumab with reference medicine Humira®* in patients with moderate-to-severe psoriasis1
  • Sandoz proposed biosimilaradalimumab is currently under review by the European Medicines Agency for the treatment of several immunological diseases
  • Sandoz is leading the way in addressing challenges around access to treatment for people living with immunological diseases 

Sandoz, a Novartis division, and the pioneer and a global leader in biosimilars, today announced new long-term data on its proposed biosimilaradalimumab from a study of patients continuously treated with the proposed biosimilar or the reference medicine. Results from the study show that efficacy and safety profiles of the two medicines match throughout 51 weeks of treatment in patients with moderate-to-severe chronic plaque psoriasis.[1] Results were presented at the 26th Congress of the European Academy of Dermatology and Venereology (EADV) in Geneva, Switzerland.

The study presented today – ADACCESS (NCT02016105) – is a Phase III confirmatory randomised, double-blind, controlled, 51-week study comparing efficacy and safety between Sandoz biosimilaradalimumab and the reference medicine. Psoriasis Area and Severity Index 75 (PASI 75) response rates for patients who received biosimilaradalimumab continuously throughout the study were 75.2% at Week 17 and 84.5% at Week 51, compared with 67.8% at Week 17 and 79.6% at Week 51 for patients who received continuous treatment with the reference medicine.1

Psoriasis affects approximately 1.8 million people in the UK.[2] Of these, approximately 25% have moderate-to-severe form of the disease – equating to 450,000 people in the UK.[3] The NHS currently spends over £416 million on adalimumab each year for the treatment of several diseases including psoriasis.[4]

“Today’s clinical data demonstrates equal efficacy and safety of biosimilaradalimumab to its originator medicine in moderate-to-severe psoriasis,” said Tim de Gavre, Country Head of Sandoz UK. “Biosimilars have real potential to expand patient access to effective treatments, while providing the NHS with essential cost savings. This opportunity has recently been recognised by NHS England; new plans could see an enhanced uptake of biosimilar alternatives to some of the most expensive medicines, providing potential savings in excess of £300m each year from the medicines bill. Today’s news reaffirms Sandoz’s leadership in the biosimilars field and strengthens our commitment to the research and development of efficacious, cost-effective biosimilar medicines.”

Sandoz is committed to increasing patient access to high-quality biosimilars. We are the pioneer and a global leader in biosimilars, with five biosimilars currently marketed worldwide, as well as a leading global pipeline. We plan to launch a total of five major oncology and immunology biosimilars between 2017 and 2020, including adalimumab, which is currently being reviewed by the European Medicines Agency.

Sandoz is well positioned to continue leading the biosimilars industry based on our experience and capabilities in development, manufacturing and commercialisation. As a division of Novartis, the first global healthcare company to establish a leading position in both innovative and off-patent medicines, we benefit strongly from this unique blend of experience and expertise in many different market environments.

[1] Blauvelt A et al. A phase III confirmatory study comparing GP2017 with reference adalimumab in patients with moderate-to-severe chronic plaque psoriasis: 51 week results from the ADACCESS study. Poster #P0405 presented at the 26th Congress of the European Academy of Dermatology and Venereology (EADV), 13–17 September 2017.

[2]Psoriasis Association.Fast facts about psoriasis. Available at: http://www.pressat.co.uk/media/uploads/aec3d9a6488c271f242e92ae0c56fb6d.pdf Last accessed September 2017.

[3]Mantovani L et al. Burden of Moderate-to-Severe Plaque Psoriasis and New Therapeutic Approaches (Secukinumab): An Italian Perspective. DermatolTher (Heidelb) 2016;6(2): 151-167.

[4] 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 September 2017.