There have been only a smattering of approvals since the start of the year. Zarxio, the first US biosimilar, was approved by the US Food and Drug Administration (FDA), and the European Medicines Agency (EMA) added to its biosimilar approvals. As Nature Biotechnology went to press, FDA was considering accelerated approval for Sarepta's eteplirsen for muscular dystrophy. Earlier, the US agency turned down PTC Therapeutics' Translarna (ataluren) and Biomarin's Kyndrisa (drisapersen) for the same indication, whereas the EMA gave the former conditional approval.
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DeFrancesco, L. Drug pipeline: 1Q16. Nat Biotechnol 34, 457 (2016). https://doi.org/10.1038/nbt.3571
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DOI: https://doi.org/10.1038/nbt.3571
