Biologic drugs are medicines that come from living organisms, like genes and proteins. Biologics make up about 5% of U.S. prescriptions, but more than 50% of total prescription drug spending in the country. Biosimilar drugs are biologic drugs that are highly similar compared to their reference products, which are existing biologics. Biosimilars are not exact…
The first biosimilar was approved in the U.S. in 2015. And now, just over 10 years later, the U.S. Food & Drug Administration (FDA) has approved an additional 81 biosimilars. In 2025 alone, the FDA approved 18 new biosimilars for a range of indications. However, only 73% of those approved biosimilars have been launched as of September 2025. Last year, the U.S. market size for biosimilars was estimated to be $22.59 billion….