FDA approves Avsola for same indications as Remicade

FDA approved Avsola (infliximab-axxq) for all approved indications of the reference product, Remicade (infliximab), including treatment of moderate-to-severe rheumatoid arthritis, moderate-to-severe Crohn’s Disease in the adult and pediatric population, moderate-to-severe ulcerative colitis in the adult and pediatric population, chronic severe plaque psoriasis, psoriatic arthritis and ankylosing spondylitis.

Avsola is sponsored by Amgen.

Avsola, an anti-tumor necrosis factor alpha 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 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 one, at weeks two and six, and every eight weeks thereafter.

The primary endpoint was the response difference of 20% improvement in American College of Rheumatology core set measurements at week 22. Key secondary endpoints included DAS28-CRP change from baseline, RD of ACR20, ACR50 and ACR70 at weeks two, six, 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, four of which have been approved in the United States, and three that are approved in the European Union.