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13-12-2019 | Rheumatology | News | Article

approvalsWatch

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.

By Claire Barnard

medwireNews is an independent medical news service provided by Springer Healthcare. © 2019 Springer Healthcare part of the Springer Nature group

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