FDAnews Drug Daily Bulletin
Pharmaceuticals / Inspections and Audits

EMA Committee Recommends Eight Medicines for Approval

Feb. 3, 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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