Adalimumab biosimilar recommended for EU approval
medwireNews: The EMA’s Committee for Medicinal Products for Human Use has recommended a new adalimumab biosimilar for approval in Europe.
Marketed under the brand name of Yuflyma, the biosimilar has been shown to have highly similar quality, safety, and efficacy to originator adalimumab. It will be available as 40 mg solution in a prefilled syringe and prefilled pen for injection.
The biosimilar will be approved for the same indications as the reference product, and can be used to treat rheumatoid arthritis, axial spondyloarthritis, psoriatic arthritis, and juvenile idiopathic arthritis, as well as non-rheumatic diseases including inflammatory bowel disease and psoriasis.
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