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HomeLatest Pharma-NewsAmgen's AVSOLA™ received FDA approval for AVSOLA™ (infliximab-axxq), For The Same Indications...

Amgen’s AVSOLA™ received FDA approval for AVSOLA™ (infliximab-axxq), For The Same Indications As Remicade® (infliximab)for the treatment of Rheumatoid Arthritis, Crohn’s Disease, Ulcerative Colitis, Psoriatic Arthritis

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.

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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).


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