FDA gives nod to adalimumab-bwwd
medwireNews: The US FDA has approved adalimumab-bwwd, an adalimumab biosimilar, for the same indications as the reference product.
These indications comprise rheumatoid arthritis, juvenile idiopathic arthritis, psoriatic arthritis, and ankylosing spondylitis, in addition to plaque psoriasis and inflammatory bowel disease.
Adalimumab-bwwd will be available as a 40 mg solution in a prefilled autoinjector. The label carries the same boxed warnings as the originator, advising caution regarding the risk for serious infection and malignancy.
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