the use of interchangeable biological products" and substituting "including, but not limited to, efficacy, the use of generic drugs, interchangeable biological products, and biosimilars."

On March 27, 2025, Tennessee's House Bill 1198 was introduced with the aim of enhancing access to biosimilar medicines, which are biologic medical products highly similar to already approved reference products. The bill seeks to amend several sections of the Tennessee Code Annotated to eliminate barriers that currently hinder patient access to these cost-effective alternatives to brand-name drugs.

The primary provisions of HB 1198 include changes to regulations governing health carriers and benefit plans. Notably, the bill prohibits health plans from requiring patients to first try an AB-rated generic or interchangeable biological product before covering the branded prescription drug. This change is intended to streamline access to biosimilars, which can significantly lower prescription drug costs for patients.

The legislative intent behind HB 1198 is clear: to increase the availability of biosimilar medicines, thereby reducing the financial burden on patients and the healthcare system. The bill aligns with findings that biosimilars meet the same rigorous FDA standards for quality, safety, and efficacy as their reference counterparts, making them a viable option for patients.

However, the bill has sparked debates among stakeholders. Proponents argue that increasing access to biosimilars will lead to substantial savings for consumers and the healthcare system, while opponents express concerns about the potential for reduced oversight and the implications for patient safety. Some healthcare providers worry that the push for biosimilars may compromise the quality of care if not managed properly.

The economic implications of HB 1198 could be significant. By facilitating access to lower-cost medications, the bill may alleviate some of the financial pressures faced by patients, particularly those with chronic conditions requiring expensive treatments. Additionally, it could lead to broader discussions about healthcare affordability in Tennessee, as rising drug costs continue to be a pressing issue.

As the bill moves through the legislative process, its future remains uncertain. Lawmakers will need to weigh the potential benefits of increased access to biosimilars against the concerns raised by various stakeholders. The outcome of this bill could set a precedent for how Tennessee approaches pharmaceutical regulation and healthcare costs in the future.

In conclusion, House Bill 1198 represents a critical step towards enhancing access to biosimilar medicines in Tennessee. Its implications for patient care, healthcare costs, and the broader pharmaceutical landscape will be closely monitored as discussions continue in the legislature.