Biogen receives European approval for new biosimilar Flixabi

Biogen has announced that its new biosimilar anti-TNF therapy Flixabi has been approved in Europe.

The European Commission has granted marketing authorisation in the EU for the new drug, an infliximab biosimilar based on the Janssen therapy Remicade. It will be the second anti-TNF biosimilar to be manufactured and commercialised by Biogen in the EU.

It is indicated for the treatment of adults with rheumatoid arthritis, Crohn's disease, ulcerative colitis, ankylosing spondylitis, psoriatic arthritis and psoriasis, as well as for patients aged six to 17 years old with severe, active Crohn's disease or severely active ulcerative colitis.

Flixabi was developed in cooperation between Biogen and Samsung Bioepis, as was the case with Benepali, the anti-TNF biosimilar that was approved in Europe earlier this year.

Both therapies offer a comparable performance to the original reference products, but can be provided at a much lower cost.

Dr Alpna Seth, senior vice-president and global head of the biosimilars business unit at Biogen, said: "We are delighted to be the first company to bring two anti-TNF biosimilars to patients and physicians across Europe."