In today’s rapidly evolving healthcare landscape, biosimilars have emerged as an option to address the demand for cost-effective and high-quality treatment options. A biosimilar is a type of biological product that shows no clinically meaningful differences from a reference Food and Drug Administration (FDA)-approved biological product. As with generic drugs, biosimilars are a subsequently approved version of the reference product and can be a clinically appropriate and less expensive option for patients.  

Generics are not the same as biosimilars: While both are lower-cost alternatives to reference brand products, biosimilars are not chemically identical to their reference compound. Unlike small molecules and their respective generics, biologics and biosimilars are derived from living cells, which inherently introduce variability in the manufacturing process and final structure. Therefore, biosimilars are not considered automatically interchangeable with their respective reference products like generics are. The FDA approves an interchangeable biosimilar when it meets additional requirements. These interchangeable biosimilars can be pharmacy-level substituted and are subject to pharmacy state laws. 

The complexities of biosimilar substitution statutes remain a challenge for prescribers, pharmacists, payers, and manufacturers. The Biosimilar Substitution Statute Report is an annually updated, comprehensive resource for manufacturers, providers, health plans, and patient advocates seeking guidance on the steps to substitution that may impact provider prescribing, pharmacy dispensing, and patient access.   

What Is In The Report?  

This report provides a comprehensive summary of state statutes on the substitution of interchangeable biosimilars for their reference biologic products. Avalere Health experts reviewed and analyzed substitution-related statutes in all 50 states, the District of Columbia, and Puerto Rico. The report highlights how these statutes vary, detailing who is authorized to make the substitution, the circumstances under which a substitution may occur, and requirements for notification and permission.  

The Biosimilar Substitution Statute Report answers key questions, including:  

This report is not an interpretation of individual product interchangeability, as designated by the FDA, nor is it a recommendation for substitution or a guarantee of insurance coverage. It does not constitute legal advice or opinion; rather, it is for general informational purposes only. Until the FDA designates a biosimilar as “interchangeable,” any state statute regarding substitution based on interchangeability by a pharmacist does not yet apply. However, this report can serve as an educational tool, providing insights into interchangeability from federal and state perspectives. It is intended to help stakeholders navigate the complexities of biosimilar substitution.

Avalere Health’s experts in commercialization, regulatory, and policy strategy can help manufacturers, patient advocacy organizations, and other stakeholders analyze the statutes and access implications to biosimilar substitution shift and help develop strategies to mitigate delays in patient access to biosimilars.  This report offers comprehensive analysis along with recently updated state legislature.

To purchase the report, contact us here.