- Samsung Bioepis received EU approval Monday for its biosimilar version of Johnson & Johnson's mega-blockbuster Remicade (infliximab). The approval covers all 28 member states of the EU, as well as the European Economic Area (EEA) member states—Norway, Iceland and Liechtenstein.
- The biosimilar copy, Flixabi, was okayed for all six of Remicade indications, covering a wide array of inflammatory conditions.
- Under the terms of Samsung Bioepsis and Biogen's co-marketing agreement for Flixabi, Biogen will lead commercialization and marketing efforts in the EU and the EEA. Samsung's South Korean rival Celltrion won approval to market its Remicade copy back in 2013.
This is the second approval of a biosimilar for Samsung Bioepis in the past five months. The South Korean biosimilar company scored the first major-market approval for an Enbrel biosimilar in January of this year when the EMA gave Benepali a green light.
Samsung has been aggressively developing a number of biosimilar copies to major biologic products which are nearing patent expiry, including for Humira, Avastin, and Lantus.
It applied for US approval of its Remicade copy earlier this month.
Additionally, the parent company of Samsung Bioepis, Samsung Biologics, is planning an IPO for Bioepis later this year, aiming to raise up to $2.5 billion, according to Reuters. The funds will likely be reinvested in R&D to drive its biosimilar pipeline candidates towards approval.
Flixabi was approved on the strength of phase 3 data from a 54-week trial, involving 584 patients with refractory rheumatoid arthritis. In the trial, Flixabi showed comparable safety and efficacy to Remicade based on an ACR20 response rate of 65.3% in the Flixabi arm versus 69.2% in the Remicade arm—confirming the results of an earlier 30-week trial that also showed comparable efficacy and safety.