OBJECTIVES: This study aims to assess the degree of convergence or divergence of regulatory frameworks for biosimilar evaluation and licensing between jurisdictions across the world and identify the current regulatory and scientific challenges with regards to biosimilarity demonstration.

METHODS: A structured literature review was carried out in scientific databases (PubMed, Embase, and Web of Science) and grey literature up to January 2023. Retrieved records were thematically categorized in a data extraction template using Microsoft Excel according to different general principles which are outlined in regulatory guidelines governing biosimilars: analytical, nonclinical, and clinical assessment.

RESULTS: The literature search yielded in total 2320 records of which 121 were selected after title and abstract screening. A total of 84 records were retrieved after the addition of records collected through other sources as well (websites, organisations, snowballing). Up to date a large variability exists in data requirements for biosimilar approval across the globe, particularly in minor jurisdictions. The current challenges revolve around divergent regulatory demands concerning the choice of the reference product, the necessary analytical tests, conducting analytical and/or PK/PD bridging studies, in vivo animal studies, comparative clinical (patient) efficacy studies, and local clinical studies, which are generally expected in most jurisdictions. In addition, regulatory requirements associated with clinical (patient) studies are not always well defined and specified in biosimilar guidelines within different jurisdictions.

CONCLUSIONS: While biosimilar development is a global undertaking, this literature study shows that current biosimilar licensing pathways vary a lot, leading to inefficiencies that might complicate the global development of biosimilars. Optimizing and streamlining regulatory frameworks and data requirements, considering the extensive knowledge gained through advancements in analytical sciences and clinical experience with biosimilars, through dialogue and collaboration between regulators across jurisdictions, is crucial for reducing development costs and enhancing patient access to biologic and biosimilar medicines across the globe.