FDA approves infliximab-axxq
medwireNews: The US FDA has approved a new infliximab biosimilar for the treatment of various types of arthritis.
Approved for the same indications as its reference product, infliximab-axxq can be given to patients with rheumatoid arthritis, psoriatic arthritis, and ankylosing spondylitis, as well as other immune-mediated conditions including ulcerative inflammatory bowel disease and plaque psoriasis.
Infliximab-axxq is administered intravenously and will be available as a 100 mg solution in a single-dose vial for infusion.
As with the originator, the label for the biosimilar carries a boxed warning for malignancy and serious infections including tuberculosis.
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