Flixabi, an infliximab biosimilar candidate referencing Remicade, receives positive CHMP opinion

Flixabi to be the second anti-TNF biosimilar commercialized and manufactured by Biogen in the EU.

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, 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 I and Phase III clinical trials comparing Flixabi to the reference product.

The 54-week, double-blind, Phase III study was conducted in patients with moderate to severe RA despite methotrexate therapy. The primary end point was the American College of Rheumatology 20% (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 Fabi had an equivalent ACR20 response and a comparable safety profile to those taking Remicade.