The US Food and Drug Administration (FDA) approved 14 new drugs in the first 6 months of this year (Table 1). These Center for Drug Evaluation and Research (CDER) approvals comprised 11 approvals for small molecules and 3 for biologics.

Table 1 FDA approvals in the first 6 months of 2015
Full size table

FDA approvals tend to be back-loaded to the second half of the year. Last year, the FDA approved 17 new drugs in the first half of the year and 24 in the second half, for a total of 41 approvals (Nat. Rev. Drug Discov. 14, 77–81; 2015).

Separately, the FDA also approved its first biosimilar drug this year: Sandoz's filgrastim-sndz, a biosimilar of Amgen's filgrastim.