The FDA has unveiled draft guidance to dramatically accelerate biosimilar development — lower-cost alternatives to high-priced biologic medicines. Though biologics represent only ~5% of prescriptions, they account for over half of all U.S. drug spending.
The new framework proposes removing the traditional requirement for large, comparative human efficacy studies, which typically took 1–3 years and cost about $24 million. Instead, developers can rely more on analytical data to prove biosimilarity.
In another major step, the FDA now no longer generally recommends “switching studies” for biosimilars seeking the interchangeable designation. This step, which is not required for generic drugs, can slow development.
Together, these actions are expected to lower development costs, increase market competition, and expand patient access to cutting-edge therapies for cancer, autoimmune disorders, and rare diseases .
This will help more companies bring affordable, high quality biosimilars to market and reduce costs for Americans.
