UK AVAILABILITY OF RIXATHON® AND ERELZI® PAVES WAY FOR NHS SAVINGS

Sandoz, a Novartis division, and the pioneer and global leader in biosimilars, today announced the UK availability of two new biosimilar medicines for use in Europe, Rixathon^® (biosimilar rituximab) and Erelzi^®(biosimilar etanercept) to treat patients with specific blood cancers and a range of inflammatory conditions. 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 availability has the potential to increase access to these medicines for eligible patients in the UK, in line with the indications of the reference medicines MabThera^®* and Enbrel^®**.

Dr. Samir Agrawal, Consultant Haematologist at St Bartholomew’s Hospitals and The Barts Health NHS Trust, said, “The availability of new biosimilar medicines – which offer equal efficacy to the originator products and provide both patients and physicians more choice in treatment options – offer a real opportunity for cost savings within the NHS, that may then be reinvested back into the health service. This comes at a crucial time for the NHS, which is currently constrained by enormous financial pressure. The hope is that rapid uptake of the medicines will translate to cost savings for the NHS which patients may quickly benefit from.”

The NHS spent £16.8 billion on medicines in 2015/16, an increase of 8 percent from the previous year.[ii] Last year, the NHS spent over £415 million on rituximab and etanercept.²The introduction of cost-effective biosimilar rituximab and biosimilar etanercept may provide much needed cost savings for the NHS, freeing up resources to improve patient access to existing medicines and contributing to its financial sustainability.

Rixathon will be available for patients with non-Hodgkin’s lymphoma (NHL) – follicular lymphoma and diffuse large B-cell lymphoma – and chronic lymphocytic leukaemia, as well as immunological diseases such as rheumatoid arthritis, granulomatosis with polyangiitis and microscopic polyangiitis. Collectively, these diseases affect approximately 416,500 people in the UK.[iii]^,[iv]

Additionally, Erelzi will be available for various patients with inflammatory conditions, including rheumatoid arthritis, axial spondyloarthritis – ankylosing spondylitis and non-radiographic axial spondyloarthritis – plaque psoriasis, psoriatic arthritis, juvenile idiopathic arthritis and paediatric plaque psoriasis. In the UK over 2.4 million people are affected by these diseases each year.4^,[v],[vi]

Commenting on the news, Tim de Gavre, Country Head of Sandoz UK, said, “The availability of Rixathon and Erelzi marks an important milestone for the NHS, for patients and for Sandoz. Biosimilar medicines such as these have real potential to expand patient access to effective treatments, while providing the NHS with essential cost savings. Today’s availability of not just one, but two, new Sandoz biosimilar medicines makes us the only company to have five approved biosimilar medicines in Europe, cementing our leadership in this space and reinforcing our commitment to providing these much-needed medicines to patients.”

Approval and subsequent availability of these medicines was based on analytical, pre-clinical, and clinical data demonstrating biosimilarity to the respective reference medicines. Clinical studies of biosimilar rituximab included a PK/PD trial in rheumatoid arthritis (ASSIST-RA), and a Phase III confirmatory safety and efficacy study in follicular lymphoma (ASSIST-FL).[vii]^,[viii] Clinical studies of biosimilar etanercept included data from an innovative Phase III confirmatory safety and efficacy study in moderate to severe plaque psoriasis (EGALITY).[ix]

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

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

[iii]NHS Choices.Non-Hodgkin lymphoma. Available at: http://www.nhs.uk/Conditions/non-hodgkins-lymphoma/Pages/Definition.aspx Last accessed June 2017

[iv]NHS Choices.Arthritis. Available at: http://www.nhs.uk/Conditions/Arthritis/Pages/Introduction.aspx Last accessed June 2017

[v]National Ankylosing Spondylitis Society.AS Employers’ Guide. Available at: http://nass.co.uk/about-as/living-well-with-as/work/ Last accessed June 2017

[vi]Psoriasis Association.About psoriasis. Available at: https://www.psoriasis-association.org.uk/psoriasis-and-treatments/ Last accessed June 2017

[vii] Smolen J et al. Pharmacokinetics, pharmacodynamics, safety and efficacy of proposed rituximab biosimilar (GP2013) vs. EU-Approved rituximab (rtx) in patients with rheumatoid arthritis: results from a randomized controlled trial (GP13-201) over 52 weeks. EULAR congress, 8-11 June 2016, London UK: FRI0222

[viii] Jurczak W et al. A Phase III Efficacy and Safety Study of the Proposed Rituximab Biosimilar GP2013 Versus Rituximab in Patients with Previously Untreated Advanced Follicular Lymphoma (link is external) ASH annual meeting, 3-6 December 2016, San Diego, USA:1809

[ix]Griffiths C et al. The EGALITY study: a confirmatory, randomized, double-blind study comparing the efficacy, safety and immunogenicity of GP2015, a proposed etanercept biosimilar, vs. the originator product in patients with moderate-to-severe chronic plaque-type psoriasis. Br J Dermatol 2016 [Epub ahead of print]

Sandoz, a Novartis division, and the pioneer and global leader in biosimilars, today announced the UK availability of two new biosimilar medicines for use in Europe, Rixathon^® (biosimilar rituximab) and Erelzi^®(biosimilar etanercept) to treat patients with specific blood cancers and a range of inflammatory conditions. 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 availability has the potential to increase access to these medicines for eligible patients in the UK, in line with the indications of the reference medicines MabThera^®* and Enbrel^®**.

Dr. Samir Agrawal, Consultant Haematologist at St Bartholomew’s Hospitals and The Barts Health NHS Trust, said, “The availability of new biosimilar medicines – which offer equal efficacy to the originator products and provide both patients and physicians more choice in treatment options – offer a real opportunity for cost savings within the NHS, that may then be reinvested back into the health service. This comes at a crucial time for the NHS, which is currently constrained by enormous financial pressure. The hope is that rapid uptake of the medicines will translate to cost savings for the NHS which patients may quickly benefit from.”

The NHS spent £16.8 billion on medicines in 2015/16, an increase of 8 percent from the previous year.[ii] Last year, the NHS spent over £415 million on rituximab and etanercept.²The introduction of cost-effective biosimilar rituximab and biosimilar etanercept may provide much needed cost savings for the NHS, freeing up resources to improve patient access to existing medicines and contributing to its financial sustainability.

Rixathon will be available for patients with non-Hodgkin’s lymphoma (NHL) – follicular lymphoma and diffuse large B-cell lymphoma – and chronic lymphocytic leukaemia, as well as immunological diseases such as rheumatoid arthritis, granulomatosis with polyangiitis and microscopic polyangiitis. Collectively, these diseases affect approximately 416,500 people in the UK.[iii]^,[iv]

Additionally, Erelzi will be available for various patients with inflammatory conditions, including rheumatoid arthritis, axial spondyloarthritis – ankylosing spondylitis and non-radiographic axial spondyloarthritis – plaque psoriasis, psoriatic arthritis, juvenile idiopathic arthritis and paediatric plaque psoriasis. In the UK over 2.4 million people are affected by these diseases each year.4^,[v],[vi]

Commenting on the news, Tim de Gavre, Country Head of Sandoz UK, said, “The availability of Rixathon and Erelzi marks an important milestone for the NHS, for patients and for Sandoz. Biosimilar medicines such as these have real potential to expand patient access to effective treatments, while providing the NHS with essential cost savings. Today’s availability of not just one, but two, new Sandoz biosimilar medicines makes us the only company to have five approved biosimilar medicines in Europe, cementing our leadership in this space and reinforcing our commitment to providing these much-needed medicines to patients.”

Approval and subsequent availability of these medicines was based on analytical, pre-clinical, and clinical data demonstrating biosimilarity to the respective reference medicines. Clinical studies of biosimilar rituximab included a PK/PD trial in rheumatoid arthritis (ASSIST-RA), and a Phase III confirmatory safety and efficacy study in follicular lymphoma (ASSIST-FL).[vii]^,[viii] Clinical studies of biosimilar etanercept included data from an innovative Phase III confirmatory safety and efficacy study in moderate to severe plaque psoriasis (EGALITY).[ix]

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

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

[iii]NHS Choices.Non-Hodgkin lymphoma. Available at: http://www.nhs.uk/Conditions/non-hodgkins-lymphoma/Pages/Definition.aspx Last accessed June 2017

[iv]NHS Choices.Arthritis. Available at: http://www.nhs.uk/Conditions/Arthritis/Pages/Introduction.aspx Last accessed June 2017

[v]National Ankylosing Spondylitis Society.AS Employers’ Guide. Available at: http://nass.co.uk/about-as/living-well-with-as/work/ Last accessed June 2017

[vi]Psoriasis Association.About psoriasis. Available at: https://www.psoriasis-association.org.uk/psoriasis-and-treatments/ Last accessed June 2017

[vii] Smolen J et al. Pharmacokinetics, pharmacodynamics, safety and efficacy of proposed rituximab biosimilar (GP2013) vs. EU-Approved rituximab (rtx) in patients with rheumatoid arthritis: results from a randomized controlled trial (GP13-201) over 52 weeks. EULAR congress, 8-11 June 2016, London UK: FRI0222

[viii] Jurczak W et al. A Phase III Efficacy and Safety Study of the Proposed Rituximab Biosimilar GP2013 Versus Rituximab in Patients with Previously Untreated Advanced Follicular Lymphoma (link is external) ASH annual meeting, 3-6 December 2016, San Diego, USA:1809

[ix]Griffiths C et al. The EGALITY study: a confirmatory, randomized, double-blind study comparing the efficacy, safety and immunogenicity of GP2015, a proposed etanercept biosimilar, vs. the originator product in patients with moderate-to-severe chronic plaque-type psoriasis. Br J Dermatol 2016 [Epub ahead of print]