Dec. 6, 2019: U.S. FDA has approved Amgen’s AVSOLA™ (infliximab-axxq) for all approved indications of the reference product, Remicade® (infliximab): for the treatment of moderate-to-severe rheumatoid arthritis (RA), chronic severe plaque psoriasis (PsO), psoriatic arthritis (PsA),ankylosing spondylitis (AS),ulcerative colitis (UC) in the adult and pediatric population, AVSOLA (monoclonal antibody), an anti-tumor necrosis factor alpha (anti-TNF) was proven to be highly similar to Remicade with no clinically meaningful differences based on a totality of evidence which incorporated comparative analytical, nonclinical and clinical data.
The randomized, double-blind comparative clinical trial study evaluated the efficacy and safety of AVSOLA as compared to Remicade in patients with moderate-to-severe RA.
There were 558 patients enrolled and randomized (1:1) to receive either AVSOLA or Remicade at a dose of 3 mg/kg administered as an infusion on day 1, at weeks 2 and 6, and every 8 weeks thereafter. The primary endpoint was the response difference (RD) of 20% improvement in American College of Rheumatology core set measurements (ACR20) at week 22. Key secondary endpoints included DAS28-CRP change from baseline, RD of ACR20, ACR50 and ACR70 at weeks 2, 6, 14, 22, 30, 34, 38, 46 and 50. The study also incorporated the evaluation of a single transition in 119 subjects from Remicade to AVSOLA at week 22, which demonstrated similar safety and immunogenicity in patients who were previously on Remicade.
Amgen has a total of 10 biosimilars in its portfolio,Ou of which four approved in the U.S. and 3 are approved in the European Union (EU). https://www.amgen.com/media/news-releases/2019/12/fda-approves-amgens-avsola-infliximabaxxq-for-the-same-indications-as-remicade-infliximab/