The FDA approved 13 new drugs in the first 6 months of this year (Table 1). These Center for Drug Evaluation and Research (CDER) approvals consisted of 8 small molecules and 5 biologics.

Table 1 FDA approvals in the first 6 months of 2016
Full size table

FDA approvals tend to be back-loaded to the second half of the year. Last year, the FDA approved 14 new drugs in the first half of the year and 31 in the second half, for a total of 45 approvals (Nat. Rev. Drug Discov. 15, 73–76; 2016).

The agency also approved one biosimilar. Celltrion's infliximab-dyyb became the first FDA-approved biosimilar of a monoclonal antibody.