Abstract

Biologic drugs account for a sizable amount of healthcare costs in the United States (US). A ‘two-tier’ regulatory system that differed between ‘biosimilar’ and ‘interchangeable’ designations, the latter frequently requiring expensive and time-consuming switching studies, was first established by the Biologics Price Competition and Innovation Act (BPCI Act) of 2010.

This article analyses the US Food and Drug Administration (FDA) draft guidance changes for 2024 and 2025, which are intended to lessen the need for comparative efficacy studies (CES) and to reduce the expectation of the requirement for specialised switching studies. It also assesses how these modifications may affect market competition and international regulatory harmonisation. The analysis compiles data from scholarly papers, FDA regulatory updates and seminal clinical trials, such as VOLTAIRE-X, EGALITY and NOR-SWITCH. Clinical evidence and growing scientific consensus show that there is very little chance of safety problems or decreased effectiveness after one or more transitions. The FDA’s evolving approach increases alignment with the European Medicines Agency (EMA) and the World Health Organization (WHO), contributing to a more harmonised global regulatory framework. It is anticipated that this regulatory simplification will result in savings of between $100 million and $300 million for each biosimilar programme, with a possible five-year total of $181 billion.