EMA gives nod to two adalimumab biosimilars
medwireNews: The Committee for Medicinal Products for Human Use has recommended two new adalimumab biosimilars for approval in Europe.
The two agents – marketed under the brand names of Kromeya and Idacio – are recommended for the same indications as adalimumab, namely rheumatoid arthritis, juvenile idiopathic arthritis, psoriatic arthritis, and axial spondyloarthritis, as well as other inflammatory diseases including psoriasis, Crohn’s disease, and ulcerative colitis.
As with the reference product, the EMA recommends that treatment with the biosimilars should be supervised by physicians experienced in the management of these conditions.
The agents will be available as a solution for injection containing 40 mg of the tumor necrosis factor inhibitor in a prefilled syringe or pen.
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