Comparable data for Benepali (etanercept biosimilar) and Flixabi (infliximab biosimilar) and SB 5 (adalimumab biosimilar) to originator drugs presented at EULAR congress. - Samsung BioLogics + Biogen

Data demonstrating long-term comparable efficacy, safety and immunogenicity of Benepali (etanercept biosimilar) and Flixabi (infliximab biosimilar) were presented by Samsung Bioepis, the joint venture between Samsung BioLogics and Biogen , at the Annual European Congress of Rheumatology (EULAR 2016), held 8�11 June in London, UK. Results showed that in patients who were switched from the reference product Enbrel to Benepali there were no treatment-emergent safety or immunogenicity issues, and efficacy was sustained for up to two years.

Comparable safety, immunogenicity and sustained efficacy were also demonstrated in patients who were switched from Remicade to Flixabi, compared with those who continued on Remicade. Benepali and Flixabi were both approved by the European Commission (EC) earlier this year and are commercialized in Europe by Biogen.

Additional data presented at the congress include results from Phase I and Phase III studies of SB5, an adalimumab biosimilar candidate referencing Humira. Results showed sustained and comparable efficacy, and comparable safety and immunogenicity profiles over 52 weeks in patients who transitioned from Humira to SB5 at Week 24, compared with patients who continued to receive the reference productvi and those who continued on SB5.