Davictrel (etanercept biosimilar) / Hanwha Solutions - LARVOL DELTA

Comparative efficacy and safety of etanercept biosimilars in comparison with etanercept in patients with rheumatoid arthritis who have insufficient response to methotrexate: A network meta-analysis. (PubMed, Int J Clin Pharmacol Ther) - "No significant difference was found between etanercept biosimilars and etanercept originators in patients with active RA despite treatment with MTX in terms of the ACR20 response rate and SAEs."

Journal • Retrospective data • Immunology • Inflammatory Arthritis • Rheumatoid Arthritis • Rheumatology

Biosimilars for RA succeed in phase III (MedPageToday) - P3, N=294; Sponsor: Hanwha Chemical; NCT01270997 & P3, N=189; “In one trial…81.36% of patients receiving etanercept and 83.48% of those given the biosimilar HD203 had a 20% improvement according to the criteria of the American College of Rheumatology (ACR20) by 6 months (P=0.6706)… in a second trial…ACR20 responses at 4 months were seen in 86.4% and 89.9% of patients receiving infliximab and those treated with BOW015…”

Conference • P3 data • Biosimilar • Rheumatoid Arthritis

A randomized, double-blind, phase 3 equivalence trial comparing the etanercept biosimilar, HD203, with Enbrel, in combination with methotrexate (MTX) in patients with rheumatoid arthritis (RA) (EULAR 2014) - Presentation time: 11.06.2014, 18:05; Abstract #OP0011; P3, N=294; Sponsor: Hanwha Chemical; NCT01270997 “…there were no statistically significant differences between proportions achieving ACR20 at weeks 12 and 48. Similar trends were seen for ACR50 and ACR70, however the proportion of patients achieving ACR50 at week 24 and 48 was higher with HD203 than with Enbrel®…. The study met the primary endpoint of demonstrating equivalence in efficacy of HD203 compared with Enbrel.”

P3 data • Biosimilar • Rheumatoid Arthritis