Biologics Share of FDA Novel Drug Approvals

## What this measures

The share of each year's new medicines that were biologics (antibodies, enzymes, other large molecules) rather than chemically made small molecules.

## Why it matters

Biologics cost more to make and face slower, costlier competition from biosimilars than small molecules face from generics, so the mix shapes the industry's long-run revenue.

## How to read it

In 2025, 26.1% of novel approvals were biologics. A 2020 law moved some protein products from NDAs to BLAs; FDA notes these in the compilation, and the share follows FDA's classification at approval.

## What it does not say

The count covers drugs reviewed by FDA's Center for Drug Evaluation and Research. Vaccines, blood products and cell and gene therapies, reviewed by the Center for Biologics Evaluation and Research, are not in it. A count says nothing about how important or how profitable the drugs are.

## Source

U.S. Food and Drug Administration: "Compilation of CDER NME and New Biologic Approvals 1985–2025" and the "Novel Drug Approvals" page for each later year. FDA website content is in the public domain.