BENEPALI®, the first etanercept biosimilar referencing Enbrel®[i], is now available in Ireland[ii] for the treatment of adults with moderate to severe rheumatoid arthritis (RA), psoriatic arthritis (PsA), axial spondyloarthritis (AxSpA), and plaque psoriasis (PsO)ii.
The originator product Enbrel®, available to patients through the HSE’s High Tech Arrangements (HT) programme, cost the Government approximately €60 million in 2014 – the second most-prescribed product on the scheme[iii].
“Anti-TNFs such as etanercept have revolutionised the outlook for patients living with conditions such as RA,” said Professor Gerry Wilson, Professor of Rheumatology at University College Dublin and Consultant Rheumatologist at St Vincent’s and Mater University Hospitals, Dublin. “The availability of an etanercept biosimilar may increase patient access to these products and allow resources to be directed toward new innovative medicines.”
Around 915,000 people in Ireland are living with some form of arthritis[iv], making it the single biggest cause of disability in the country.
BENEPALI’s® availability comes shortly after the publication of the Health Protection Regulatory Authority’s (HPRA) first biosimilars guide[v], which is targeted at doctors and provides information on the regulation, prescribing, dispensing and traceability of biosimilar medicines in Ireland.
Mr John Church, CEO of Arthritis Ireland, also welcomed the availability of BENEPALI®: “Arthritis Ireland is glad that the significant number of people in Ireland with RA, PsA, AxSpa and PsO may now avail of etanercept at a lower cost. This may potentially expand the number of patients who can benefit from this important treatment option.”
“It is great news for patients that, with the introduction of our first biosimilar in Ireland, doctors have a new treatment option that may help reduce expenditure and support ongoing patient access to anti-TNF therapy,” said Mr Darren Clarkson, Regional Director, Biosimilars UK/Ireland at Biogen. “Biogen has a rich heritage in biologics, and we are proud to be launching the first etanercept biosimilar in Ireland.”
BENEPALI (etanercept), formerly known as SB4, is the first biosimilar referencing Enbrel, and is the first subcutaneous anti-TNF biosimilar available in Ireland. It was developed by Samsung Bioepis, a joint venture between Biogen and Samsung BioLogics. The EC approval was based on a robust preclinical and clinical data package submitted to the European Medicines Agency by Samsung Bioepis. The data in the preclinical submission leveraged sophisticated molecular analytics and technical development. Confirmatory data from well-controlled, head-to-head Phase 1 and Phase 3 clinical trials compared BENEPALI to Enbrel. The 52-week, doubleblind, Phase 3 study randomised 596 patients with moderate to severe RA despite methotrexate therapy, across more than 70 sites in 10 countries to receive BENEPALI or Enbrel in a 1:1 ratio. Analysis of the primary endpoint at week 24 showed that BENEPALI had equivalent efficacy to Enbrel, as shown by an ACR20 response of 78.1% in the BENEPALI arm versus 80.3% in the Enbrel arm.