The results of a Phase III study of LBEC0101, a biosimilar to Enbrel (etanercept) developed by Korean pharmaceutical company LG Chem, have been published.  The study evaluated the similarities between LBEC0101 and the etanercept reference product (ETN-RP) in terms of efficacy and safety, including immunogenicity, in patients with active rheumatoid arthritis despite methotrexate treatment.  The study concluded that “the clinical efficacy of LBEC0101 was equivalent to that of ETN-RP. LBEC0101 was well tolerated and had a comparable safety profile to ETN-RP.”

The authors noted that because the study was conducted only in Japan and Korea, “the generalisability of the findings may be limited to the Asian population and a longer term study is warranted.”  They further noted that “based on the known ETN-RP properties and the high similarity between LBEC0101 and ETN-RP, LBEC0101 is very likely to be insensitive to both intrinsic and extrinsic ethnic factors.”