EU Grants Approval to Remicade Biosimilar Flixabi

On May 30, Samsung Bioepis announced that its biosimilar candidate SB2, launched in partnership with Biogen, received approval from the European Commission and will be available for use in 28 European Union (EU) member states. Named Flixabi, the biosimilar to Johnson & Johnson/Merck’s Remicade (infliximab) will be marketed and distributed in the EU by Biogen.

Flixabi demonstrated comparable safety and efficacy to Remicade in a 54-week Phase III clinical study of 584 patients with rheumatoid arthritis, producing an American College of Rheumatology 20% (ACR20) response rate of 65.3% compared with Remicade’s rate of 69.2%. Flixabi is approved in Europe for the inflammatory conditions rheumatoid arthritis, Crohn’s disease, ulcerative colitis, ankylosing spondylitis, psoriatic arthritis, and psoriasis.

The approval of Flixabi makes Biogen "the first company to bring two anti-TNF biosimilars to patients and physicians across Europe," the company wrote in a press statement, and Samsung is the first company to develop a second anti-TNF therapy in Europe. To be clear, Samsung Bioepis is a joint venture between Samsung BioLogics and Biogen. Flixabi follows Biogen’s marketing of Benepali, also known as SB4, a biosimilar referencing Amgen's Enbrel (etanercept), across the EU.

On May 24, 2016, Samsung Bioepis announced that FDA accepted for review the company’s Biologics License Application (BLA) for SB2. If approved in the US, Merck would handle the marketing and distribution of SB2.

Sources: Samsung Bioepis, Biogen