Flixabi, Biogen’s infliximab biosimilar referencing Remicade, approved in the EU

Biogen to manufacture and commercialize Flixabi, the company’s second anti-TNF biosimilar therapy in the EU.

Flixabi will be the second anti-TNF biosimilar to be manufactured and commercialized by Biogen in the EU. Earlier this year, Samsung Bioepis received approval for Benepali (etanercept), a biosimilar referencing Enbrel. Biogen has since launched Benepali in several countries across the EU. At an estimated $10 billiona year, anti-TNF therapies are among the EU’s largest drug expenditures. Benepali and Flixabi will offer physicians alternatives that will drive meaningful savings across the EU.

“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 commercializing 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,” said Alpna Seth, 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.”

As part of the submission, Samsung Bioepis provided a robust preclinical and clinical data package from head-to-head Phase I and Phase III clinical trials comparing Flixabi with the reference product Remicade. Following biosimilar approval guidelines from the European Medicines Agency, the Phase III clinical trial for Flixabi was performed to confirm equivalent efficacy, and to compare safety and immunogenicity with Remicade. 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% (ACR20) response at week 30 in the per-protocol set (PPS).vii The primary end point for the study was met, with data showing that patients taking Flixabi had an equivalent ACR20 response and a comparable safety profile to those taking Remicade.