The Legal and Regulatory Status of Biosimilars: How Product Naming and State Substitution Laws May Impact the U.S. Healthcare System

Abstract

Alongside the Constitutional controversy ultimately addressed by the Supreme Court, the colossal Patient Protection and Affordable Care Act (ACA) ushered in a new paradigm for regulation of biologics by the Food and Drug Administration (FDA). Nestled within the expansive ACA, the Biologics Price Competition and Innovation Act (BPCIA) set forth an abbreviated pathway to market for “biosimilar” and “interchangeable” biosimilar biological products. While the current BPCIA implementation debate focuses chiefly on the scope of scientific and technical assessments by the FDA and the effect on the emergent biosimilar industry, two issues will prove essential for determinations of access to and costs of the resulting products: how the biosimilar and interchangeable biosimilar biologics are to be named, and whether pharmacist substitution is appropriate for products deemed interchangeable by the FDA.

Both naming practices and state substitution laws will have tremendous ramifications on physician prescribing, pharmacist practices, and ultimately, patient choice and overall costs to the U.S. health care system. However, both are in a troubling state of flux. The FDA has thus far sidestepped the naming question because of the nascent state of the regulatory pathway to market and a total lack of tangible products as of early 2015. The application of current international naming regimes is being contemplated, as is the development of unique identifiers. In addition, states are just beginning to confront the issue of how to extend or adapt pharmacist substitution laws to biosimilar products, with eight state laws enacted since 2013 and over a dozen more considered. This flurry of legislative activity is being driven by industry interests and is not without criticism.

This article examines the current debate surrounding the use of nonproprietary names for biosimilar biologics, as well as state efforts to reconcile automatic substitution laws for the eventual products. Part II of the article sets forth the statutory basis and history of the generic drug approval pathway for traditional chemical molecules and the concept of therapeutic equivalence. It also reviews the nonproprietary naming system employed for brand and generic drugs from both an international and a U.S. perspective. Part III addresses the importance of the product name of an FDA-regulated drug or biologic for labeling requirements, adverse event reporting and pharmacovigilance, and post-market label changes. Part IV explains the foundational definitions and basic requirements set forth in the BPCIA for biosimilar and interchangeable biosimilar products, as well as the current state of guidance from the FDA framing these requirements. It also compares traditional drugs and biologics with regard to complexity, characteristics, and measures of comparison.

The article then focuses on numerous challenges posed by product naming and substitution laws for biosimilar biologics. Part V examines the current debate regarding the naming of biosimilar products and reflects on lessons from the European Union in this realm. Part VI addresses the role of state substitution laws for generic drugs and discusses recent state legislative efforts aimed at extending or modifying the substitution laws for biological products. It also assesses the various positions held by industry, advocacy groups, and professional organizations on the scope of these laws and proposed bills. Part VII discusses the implications for patients and the U.S. health care system, particularly highlighting the potential negative effect on anticipated cost-savings, hindrance for effective tracking and reporting of adverse events, and a general lack of consistency in state laws.

Keywords: biosimilars, biologics, FDA, naming, substitution, health care, Biologics Price Competition and Innovation Act, Affordable Care Act