US Food and Drug Administration approvals continue to lag behind the European Medicine Agency (EMA), particularly with the US government shutdown; 2013 is shaping up as a very poor year for first-in-class drug approvals. EMA approved the first biosimilar monoclonal antibody; Biogen, Pharmacyclics, Clinuvel, Actelion and Celgene all await final regulatory decisions.
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DeFrancesco, L. Drug pipeline 3Q13. Nat Biotechnol 31, 956 (2013). https://doi.org/10.1038/nbt.2746