FDA approves adalimumab biosimilar
medwireNews: The US FDA has approved another adalimumab biosimilar, adalimumab-adaz, for the treatment of a number of rheumatic diseases.
This announcement follows the approval of the agent in Europe earlier in 2018.
The US approval of adalimumab-adaz covers the same indications as the reference product, namely rheumatoid arthritis, juvenile idiopathic arthritis, psoriatic arthritis, and ankylosing spondylitis, as well as Crohn’s disease, ulcerative colitis, and plaque psoriasis.
As with adalimumab, the biosimilar carries a boxed warning for serious infection and malignancy risk.
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