FDA approves Avsola, infliximab biosimilar, for all indications of the reference product.- Amgen

Amgen has announced that the FDA has approved Avsola (infliximab-axxq) for all approved indications of the reference product, Remicade (infliximab): for the treatment of moderate-to-severe rheumatoid arthritis (RA), moderate-to-severe Crohn's Disease (CD) in the adult and pediatric population, moderate-to-severe ulcerative colitis (UC) in the adult and pediatric population, chronic severe plaque psoriasis (PsO), psoriatic arthritis (PsA) and ankylosing spondylitis (AS). Avsola, an anti-tumor necrosis factor alpha (anti-TNF) monoclonal antibody, was proven to be highly similar to Remicade with no clinically meaningful differences based on a totality of evidence which included comparative analytical, nonclinical and clinical data. The data package was composed of, in part, results from a pharmacokinetic (PK) similarity study conducted in healthy subjects, and a comparative clinical study conducted in patients with moderate to severe RA. The randomized, double-blind comparative clinical study evaluated the efficacy and safety of Avsola 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.