The FDA today approved its fourth biosimilar, a tumor necrosis factor inhibitor similar to adalimumab.
The US Food and Drug Administration (FDA) today approved a new biosimilar.
The biosimilar is adalimumatto (Amjevita/Amgen)) and it is believed to be equivalent to adalimumab (Humira/AbbVie).
The product is indicated for treating rheumatoid arthritis (RA) active psoriatic arthritis, active ankylosing spondylitis, Crohn's disease, ulcerative colitis, and plaque psoriasis.
Amjevita is also indicated for moderately to severely active polyarticular juvenile idiopathic arthritis in patients four years of age and older, the FDA said.
This is the fourth FDA-approved biosimilar.
"The biosimilar pathway is still a new frontier and one that we expect will enhance access to treatment for patients with serious medical conditions,” said Janet Woodcock, M.D., director of the FDA’s Center for Drug Evaluation and Research, as quoted in a news release.
Like Humira, the biosimilar will come with a boxed warning citing the risk of users developing lymphoma and other m alignancies in patients treated with tumor necrosis factor blockers like adalimummab.