The approval is in keeping with a recommendation by the European Medicines Agency (EMA). In April the agency said the drug - Flixabi – has comparable quality, efficacy and safety to Janssen’s originator Remicade, which is sold in Europe by Merck & Co.
The approval applies to all 28 European Union (EU) member states and Norway, Iceland and Liechtenstein.
Flixabi is the second biosimilar Samsung Bioepis – a joint venture between Samsung Biologics and Biogen – has had approved in Europe.
In January the Commission cleared Benepali, a version of Amgen’s autoimmune disease treatment Enbrel (etanercept).
The products both mediate their therapeutic effect by inhibiting the cytokine tumor necrosis factor alpha (TNF-alpha), which is involved in autoimmune responses.
Manufacturing
Both drugs were filed in Europe by the firm’s recently established entity Samsung Bioepis UK, however, neither will be made in the UK.
A Samsung Bioepis spokesman told us "we ensure the reliable supply of our products by using multiple contract manufacturing organizations."
One of these contractors will be Biogen, which will make both Flixabi and Benepali at its facility in Hillerød, Denmark
Biogen will also be instrumental in making Flixabi available to patients according to the spokesman.
"In accordance with a commercialization agreement signed between Samsung Bioepis and Biogen, Biogen will commercialize Flixabi in the EU and the relevant EEA member states."
Flixabi – which is also known as SB2 - was approved in Korea, Samsung Bioepis’ home market, in December as Renflexis.