samsung_bioepis

First Enbrel biosimilar launches in UK

pharmafile | February 16, 2016 | News story | Manufacturing and Production, Research and Development Enbrel, Samsung Bioepis, eternacept, rheumatoid arthritis 

Following its approval by the European Commission in January, Benepali has become the first biosimilar of Pfizer/Amgen’s Enbrel (etanercept) to launch in the UK.

The biosimilar, developed by Samsung Bioepis, a joint venture between Biogen and Samsung BioLogics, proved equal to the reference product in a Phase III trial of 596 patients in 10 countries, convincing the European Medicines Agency to give its backing in January.

It is now available to UK patients for the treatment of moderate to severe rheumatoid arthritis (RA), psoriatic arthritis (PsA), axial spondyloarthritis (Ax-SpA) and plaque psoriasis (PsO). 

More than two million people in the UK are estimated to be living with the long-term inflammatory diseases that Benepali treats, and biologic medicines have proven effective at treating their symptoms.

Enbrel and Benepali belong to a class of treatments known as Anti-tumour necrosis factor (anti-TNF) drugs, which supress the inflammatory immune responses seen with these diseases. Anti-TNFs represent approximately 5% of NHS expenditure on medicines, with etanercept expenditure third-highest of all medicines prescribed in the UK.

The biosimilar version will offer cost savings over the original, which is marketed by Amgen within the US and Canada, and Pfizer in all other markets. In 2015, the drug made the US pharma giant $3.33 billion, but Benepali will be positioned to eat into such sales in a similar manner to Remsima for Remicade.

Merck has lost some 5% market share and 13% of sales for its original since the launch of Celltrion/Hospira’s infliximab biosimilar in major European markets in Q2 2015.

Professor Peter Taylor, Professor of Musculoskeletal Sciences, Kennedy Institute of Rheumatology, University of Oxford, hailed the opportunity for the health service to make cost savings following the launch. Budget studies suggest the use of eternacept biosimilars across the UK over the next five years could save the NHS as much as £380 million, and £200 million in RA alone.

 “Anti-TNFs such as etanercept have revolutionised the outlook for patients living with conditions like RA. The availability of an etanercept biosimilar comes shortly after new NICE guidance recommending patients with severe RA should be started on a more cost-effective treatment option. Biosimilars offer an opportunity to help reduce NHS costs and potentially expand the number of patients who can benefit from these important treatment options.”

“It is great news for patients that, with the introduction of our first biosimilar in the UK, doctors have a new treatment option which may help reduce expenditure and support ongoing patient access to anti-TNF therapy,” adds Darren Clarkson, regional director, Biosimilars UK/Ire/NL at Biogen. “Biogen has a rich heritage in biologics, and we are proud to be launching the first etanercept biosimilar here in the UK.”

Joel Levy

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