This study performs a cross-national comparison of biosimilar approvals by thirteen regulatory authorities (RAs) in Argentina, Australia, Brazil, Chile, Canada, Colombia, Europe, Hungary, Guatemala, Italy, Mexico, Peru and the United States. Biosimilars are biological medicines highly similar to a previously authorized reference product and their approval is expected to improve access to biological therapies.
All RAs had published guidelines for the authorization of biosimilars, and three of them had issued summary technical reports on the technical evaluation of medicines for approval. However, only three RAs had published public evaluation reports for registration applications, indicating differences in the transparency of approval processes.
The number of approved biosimilars varied considerably between jurisdictions, with numbers ranging from 19 to 78 approved biosimilars. Most biosimilars had been authorized between 2018 and 2020.
Despite the increase in the number of products in recent years, some challenges remain in accessing information on the evaluation of biosimilars by RAs, which could affect confidence and, ultimately, the adoption of these products in clinical practice.
This study highlights the importance of transparency in the biosimilar approval process and the need to address differences in approval policies for these products between different jurisdictions. Furthermore, it underlines the importance of continuing to monitor and evaluate the availability and access to biosimilars in different countries to improve access to biological therapies.
