Biogen receives CHMP backing for EU Flixabi approval

Biogen has announced that its new biosimilar product Flixabi has been recommended for European regulatory approval.

The European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) has issued a positive opinion for the marketing authorisation of Flixabi in the same indications as Remicade, the branded product on which the biosimilar is based.

Developed by Samsung Bioepis, the drug offers a similar performance to Remicade in the treatment of rheumatoid arthritis, Crohn's disease, ulcerative colitis, ankylosing spondylitis, psoriatic arthritis and psoriasis.

It can also be used in patients six to 17 years old with severely active Crohn's disease or severely active ulcerative colitis.

This recommendation for approval was based on positive results from head-to-head phase I and phase III clinical trials comparing Flixabi to the reference product.

Dr Alpna Seth, senior vice-president and global head of the biosimilars business unit at Biogen, said: "The positive CHMP opinion for Flixabi marks another important milestone for our biosimilars business this year. We are excited to harness this positive momentum as we prepare to bring our second biosimilar treatment to patients in the EU."