Posted by Michael Wonder on 06 Dec 2019
FDA approves Amgen's Avsola (infliximab-axxq), for the same indications as Remicade (infliximab)
6 December 2019 - Amgen's fourth FDA approval from biosimilars portfolio.
Amgen today announced that the U.S. 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, moderate-to-severe Crohn's disease in the adult and paediatric population, moderate-to-severe ulcerative colitis in the adult and pediatric population, chronic severe plaque psoriasis, psoriatic arthritis and ankylosing spondylitis.
The randomised, double-blind comparative clinical study evaluated the efficacy and safety of Avsola compared to Remicade in patients with moderate-to-severe rheumatoid arthritis.
