Biogen receives marketing authorisation in the EU for infliximab biosimilar

Drugs company Biogen has just announced that it has been granted marketing authorisation in the EU for Flixabi, a biosimilar to infliximab indicated for the treatments of adults with rheumatoid arthritis, Crohn’s disease, ulcerative colitis, ankylosing spondylitis, psoriatic arthritis and psoriasis. Additionally, Flixabi can be used in patients from six to 17 years old with severe, active Crohn’s disease or severely active ulcerative colitis.

Developed by Samsung Bioepis, the joint venture between Samsung BioLogics and Biogen, Flixabi will be the second anti-TNF biosimilar to be manufactured and commercialised by Biogen in the EU.

As part of the submission, Samsung Bioepis provided robust preclinical and clinical data from head-to-head Phase 1 a phase 3 randomised clinical trials comparing Flixabi with infliximab (Remicade, Janssen Biotech).

“The approval of FLIXABI marks a major step forward for both Samsung Bioepis and Biogen. It expands our anti-TNF portfolio and furthers Biogen’s commitment to commercialising biosimilars of advanced biologics, while expanding cost-effective treatment options for patients living with chronic inflammatory conditions such as Crohn’s disease and ulcerative colitis,” says Alpna Seth, Ph.D., Senior Vice President and Global Head of the Biosimilars Business Unit at Biogen. “We are delighted to be the first company to bring two anti-TNF biosimilars to patients and physicians across Europe.”

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