The first biosimilar version of Pfizer/Amgen's big-selling tumour necrosis factor (TNF) inhibitor Enbrel has been given a green light in Europe.
The European Commission approved Samsung Bioepis' Benepali version of Enbrel (etanercept) for the treatment of adults with moderate to severe rheumatoid arthritis, psoriatic arthritis, non-radiographic axial spondyloarthritis and plaque psoriasis. The drug was previously known as SB4.
Enbrel is one of the top-selling drugs in the TNF inhibitor class and the fourth-biggest selling medicine in 2014, bringing in more than $9bn in sales for Pfizer and Amgen in that year. It is second only to AbbVie's $13bn-a-year Humira (adalimumab) in the anti-TNF market.
Samsung Bioepis - a joint venture between South Korean electronics group Samsung and Biogen - said it plans to launch the product onto its first European markets within the next few weeks. It is already available in South Korea, where it is marketed as Brenzys.
Once launched it will be the second biosimilar anti-TNF drug available in Europe, after Celltrion and Hospira's Inflectra/Remsima, approved last year as the first biosimilar versions of Janssen/MSD's Remicade (infliximab).
It will also be the first biosimilar in the class available as a subcutaneous injection, according to the company, which is also developing biosimilar versions of both Remicade (SB2) and Humira (SB5). All told, the European market for anti-TNF therapies is estimated at around $10bn.
Benepali was granted a positive opinion by the Committee for Medicinal Products for Human Use (CHMP) last November.
"For more than 15 years, anti-TNF therapies have revolutionised the care and outlook for patients living with chronic inflammatory diseases such as RA," said Professor Peter Taylor, a rheumatology specialist based at the University of Oxford.
"However, access to these highly-effective treatments has been restricted by high costs [and] the development of biosimilar drugs is a welcome solution to help alleviate some challenges with access," he added.