Innovator and biosimilar drug approvals in 2024 down on prior year

17 July 2025

The US Food and Drug Administration (FDA) announced the approval of 127 innovator and biosimilar drugs in 2024, a notable decrease from the 149 approvals recorded in 2023.

Despite the 15% decline in overall approvals, the year saw a remarkable surge in innovative drug approvals, particularly from small pharma companies, many of which secured their first market approvals.

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