Home » EMA Committee Recommends Eight Medicines for Approval
EMA Committee Recommends Eight Medicines for Approval
February 2, 2017
The European Medicines Agency’s Committee for Medicinal Products for Human Use issued positive opinions for eight medicines — including two biosimilars.
The two biosimilars are Amgen products: Solimbic, for treating psoriatic arthritis, Crohn’s disease, and ulcerative colitis, among other conditions; and Amgevita, known as Amjevita in the U.S., for the treatment of rheumatoid arthritis and other inflammatory diseases.
The expert committee also issued a positive opinion on a hybrid application for Therakind’s Jylamvo for treatment of acute lymphoblastic leukemia, severe psoriasis and arthritis. Hybrid applications rely in part on data for a reference product and in part on new data.
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