Samsung Bioepis first to receive EC approval for a third anti-TNF biosimilar

September 5, 2017 11:08 AM

imraldi-adalimumab-samsungbioepis-biosimilarnews-logo

Samsung Bioepis Co., Ltd. last week announced the European Commission’s (EC) approval of Imraldi, a biosimilar referencing Humira (adalimumab).

Imraldi is approved for the treatment of rheumatoid arthritis, juvenile idiopathic arthritis, axial spondyloarthritis, psoriatic arthritis, psoriasis, pediatric plaque psoriasis, adult and adolescent hidradenitis suppurativa, Crohn’s disease, pediatric Crohn’s disease, ulcerative colitis and uveitis.

With the EC’s marketing authorization of Imraldi, Samsung Bioepis becomes the industry’s first to European approvals for biosimilars referencing all three anti-TNF-alfa blockbusters. Benepali (etanercept) and Flixabi (infliximab) received EC marketing authorization in January 2016 and May 2016, respectively.

“We are proud to become the industry’s first to obtain European approval for a third TNF inhibitor. This is a testament to our agile biologics development platform, which has allowed us to develop approved biosimilars in less time at lower cost,” said Christopher Hansung Ko, President & CEO of Samsung Bioepis. “Through relentless process innovation and an uncompromising commitment to quality, we remain dedicated to advancing one of the industry’s strongest biosimilar pipelines, so that more patients and healthcare systems across Europe will benefit from biosimilars.”

The EC approval of Imraldi applies to all 28 European Union (EU) member states as well as the European Economic Area (EEA) member states of Norway, Iceland and Liechtenstein. Biogen will commercialize Imraldi in the EU and EEA member states.

The EC approval of Imraldi follows a positive opinion from the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) in June 2017.

Leave a Reply

Twitter ID
(ID only. No links or "@" symbols)


Latest News on Biosimilar News

Share an Article?

Writing an article is not only a great way to share your knowledge, but it is also a great way to give back to the community.

We value all our contributors and if you have a website, we will surely give a link back to your site and products.
Wanna contribute?

Suggestions?

Biosimilar News was started for the people who are interested in this rapidly growing business area. So if you have suggestions or feedback on how we can improve, please let us know. If you want to see a specific topic covered, answer to a specific question, or anything else of this sort, just write us. We do our best to keep up!
Make a suggestion now!