The Committee for Medicinal Products for Human Use (CHMP) has issued a positive opinion for the marketing authorisation of Flixabi (infliximab). Previously known as SB2, Flixabi is an infliximab biosimilar candidate referencing Remicade, which was developed by Samsung Bioepis, the joint venture between Samsung BioLogics and Biogen.

The positive opinion will now be referred to the European Commission (EC), which grants marketing authorisation for medicines in the European Union (EU). If approved by the EC, Flixabi could be prescribed in the same indications as Remicade. This includes treatment of adults with rheumatoid arthritis (RA), Crohn’s disease, ulcerative colitis, ankylosing spondylitis, psoriatic arthritis, and psoriasis. Flixabi could also be used in patients six to 17 years old with severe, active Crohn’s disease or severely active ulcerative colitis.

The positive CHMP opinion comes shortly after marketing authorization was granted for Benepali (etanercept), a biosimilar referencing Enbrel. Both Flixabi and Benepali are anti-TNF therapies, a treatment class which accounts for the largest prescribed segment of the global biologics market.

“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,” said Alpna Seth, Ph.D., senior vice president and global head of the biosimilars business unit at Biogen. “Biogen is building upon its deep expertise in manufacturing and commercializing biologics for immunological conditions by bringing forth these important therapies. Biosimilars will increase choice and access for patients in the EU, while providing potential cost savings to healthcare systems.”

The CHMP’s positive opinion was based on a robust preclinical and clinical data package submitted to the European Medicines Agency by Samsung Bioepis. Data in the preclinical submission established similarity and comparability between Flixabi and its reference product, Remicade. The clinical submission included confirmatory data from head-to-head phase 1 and phase 3 clinical trials comparing Flixabi to the reference product.

The 54-week, double-blind, phase 3 study was conducted in patients with moderate to severe RA despite methotrexate therapy. The primary end point was the American College of Rheumatology 20 per cent (ACR20) response at week 30 in the per-protocol set (PPS). ACR20 evaluates effectiveness of RA treatments by measuring improvement in physical and clinical measures, including tender and swollen joint counts, a key symptom of RA. The primary end point for the study was met, with data showing patients taking Flixabi had an equivalent ACR20 response and a comparable safety profile to those taking Remicade.

A total of 584 patients were randomized in a 1:1 ratio to either Flixabi (N=291, 290 analyzed) or Remicade (N=293).

The ACR20 response rate at week 30 in the PPS showed equivalence of Flixabi to Remicade: 64.1 per cent vs. 66.0 per cent, respectively (adjusted difference -1.88 per cent; 95 per cent CI -10.26 per cent to 6.51 per cent). The ACR20 response rate at week 54 in the PPS confirmed equivalent efficacy, with results showing 65.3 per cent vs. 69.2 per cent, respectively (adjusted difference 3.07 per cent; 95 per cent CI: 12.00 per cent to 5.86 per cent)iv

ACR20 response in the full analysis set at week 30 and week 54 also showed equivalence of Flixabi to Remicade: 55.5 per cent vs. 59.0 per cent, respectively (adjusted difference 2.95 per cent; 95 per cent CI: 10.88 per cent to 4.97 per cent) at week 30 and 50.7 per cent vs. 52.6 per cent, respectively (adjusted difference 1.15 per cent; 95 per cent CI: 9.16 per cent to 6.86 per cent) at week 54iv

Flixabi was well tolerated with comparable safety, pharmacokinetics and immunogenicity to Remicade.