Please login to the form below

Not currently logged in
Email:
Password:

Biogen-Samsung's Enbrel biosimilar cleared for EU marketing

The companies plan to launch the treatment in the coming weeks
European Commission

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.

Article by
Phil Taylor

18th January 2016

From: Regulatory

Share

Tags

Featured jobs

Subscribe to our email news alerts

PMHub

Add my company
inVentiv Health

inVentiv Health is a global professional services organization designed to help the biopharmaceutical industry accelerate the delivery of much-needed therapies...

Latest intelligence

Leveraging HCP Transparency Insights to Drive Future Customer Investments
EFPIA’s disclosure requirements present an opportunity to assess strategy and effectiveness...
How did pharma use Twitter at #ASCO16?
Each year, ASCO’s Annual Meeting brings together 30,000 oncology professionals from around the world, here we explore the #ASCO16 hashtag and how pharma utilised the channel during this year's event....
WHITE PAPER: How to engage with HCPs more effectively
Shrinking budgets and limitations on the time HCPs can spend with sales reps is making traditional engagement methods more and more ineffective. So, in order to reach the unreachable, pharma...

Infographics