On January 12, the Brussels-based GaBI Journal published an editorial by ASBM Executive Director Michael Reilly, Advisory Board Chair Philip Schneider, and Steering Committee member Andrew Spiegel examining an abrupt and troubling shift in U.S. biosimilars policy.

In the article, the authors argue that while biosimilars have consistently demonstrated safety and effectiveness, they are not – and cannot be -equated with small-molecule generics. Unlike generics, biologics are large, complex molecules that cannot be fully characterized by analytical testing alone. As the authors explain, even small differences in structure, formulation, delivery device, or conditions of use can have clinically meaningful effects—making a generic-style regulatory model scientifically inappropriate.

The central thesis of the article is that FDA’s recent efforts to “genericize” biosimilars risk eroding the scientific foundation of biologics regulation. By signaling reduced expectations for clinical evidence and encouraging broader automatic substitution, FDA departs from both the intent of the Biologics Price Competition and Innovation Act and the longstanding global consensus that biosimilars require a distinct, evidence-based framework. The authors warn that this shift could undermine physician and patient confidence, jeopardize informed decision-making, and ultimately weaken trust in biologic medicines.

The editorial contrasts FDA’s direction with the approaches of other major regulators—including the EMA, WHO, and Health Canada, which continue to emphasize the unique nature of biologics and the importance of tailored regulatory standards rather than a one-size-fits-all generic paradigm.

Read the full article here.