FDA Eases Biosimilar Approvals, but Patent Hurdles Remain

As of November 2025, the U.S. Food and Drug Administration (FDA) has announced plans to streamline the regulation of biosimilar drugs, aiming to halve the time and money needed to bring these affordable alternatives to market. Biosimilars are essentially generic versions of biologic drugs, which are made from living organisms and can cost up to 90% less than brand-name versions.

However, the U.S. patent office has been working against this effort, making it more difficult for biosimilar makers to challenge the numerous patents that brand-name drugmakers file to protect their products. This "patent dance" can delay biosimilar competition for years, even after FDA approval.

While the FDA's new guidance could save biosimilar companies up to $100 million per drug, the patent office's actions have restricted the opportunities for these companies to invalidate brand-name patents through a sped-up review process. This has left patients waiting for more affordable options, as only about 10% of the 118 biologics set to come off patent in the next decade have biosimilars in development.