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Fresh from the biotech pipeline—2018

The FDA approved record numbers of new molecular entities, orphan drugs, small-molecule generics and biosimilars in 2018. Could industry’s regulatory success of the past two years become the new normal?

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Fig. 1: 2018 FDA approvals.
Fig. 2: 2018 NME approvals by therapeutic class.
Fig. 3: 2018 NME approvals by company category.
Fig. 4: Biosimilar approvals in the US.