On October 29, the U.S. Food and Drug Administration (FDA) unveiled new draft guidance aimed at speeding up the approval process for biosimilars—lower-cost alternatives to brand-name biologic drugs. This initiative is part of the FDA’s broader effort to reduce healthcare costs by fostering competition and expanding access to life-saving biologic treatments, which are often priced at a premium.
The new framework presents significant changes in the approval process, particularly by eliminating the need for large-scale comparative clinical trials for many biosimilars. Instead, biosimilar applicants will be able to rely on advanced analytical and immunogenicity data to demonstrate their products’ similarity to the reference biologic. This change is expected to simplify and accelerate the approval process for biosimilars, which traditionally require extensive testing before they can be approved for use.
Biologic drugs currently account for a small percentage of all prescriptions in the U.S.—around 5%—but they represent a disproportionate share of total drug spending. According to FDA estimates, biologic medicines are projected to account for over half of the nation’s total drug spending in 2024. Given their high cost, biosimilars have been seen as a potential solution to help reduce healthcare costs, especially for patients who rely on biologic treatments for chronic conditions such as autoimmune diseases or cancer.
Industry groups have expressed support for the FDA’s new initiative. The American Society of Health-System Pharmacists (ASHP) has lauded the decision to eliminate “switching studies,” which are typically required when patients switch from one biologic drug to another. According to the ASHP, this change is a meaningful step forward in making biosimilars more accessible and viable as alternatives in routine pharmacy practice.
While the draft guidance is not binding and is still open to public comment, its adoption is seen as a potential game-changer in the biosimilar development landscape. Experts predict that the new framework could shorten the development timeline for biosimilars, which typically takes between 5 and 8 years, and significantly reduce costs associated with their development, which can exceed $100 million for each biosimilar.
For patients, the long-term implications are significant. The new guidance could lead to a broader range of biologic therapies becoming available at lower prices, making life-saving treatments more affordable and accessible. The draft guidance is still in its early stages, but as it moves toward finalization, both manufacturers and health systems will be keeping a close watch on how these changes impact the biosimilar market and the broader healthcare system.
The FDA’s move to accelerate biosimilar drug approvals reflects the growing push to address the rising costs of biologic therapies and make them more accessible to patients. By simplifying the approval process, the FDA is not only encouraging competition but also taking an important step in ensuring that more patients can benefit from affordable biologic treatments. As the guidance moves closer to finalization, stakeholders across the healthcare industry will be looking for further details on its implementation and its potential to reduce the financial burden on patients and the healthcare system.
