Evolution of International Standards for the Approval of Biosimilars: A Path to Flexibilities

The availability of competitors from generic versions of biotherapeutics, known internationally as biosimilars, is critical for patients who require them to have access to treatment and for the sustainability of healthcare systems. The presence of competition is conditioned by the regulatory processes and the approval of health agencies. In the last decade, technological and scientific developments for protein characterization and clinical results in the real-life usage of biosimilars have supported the adoption of flexibilities for their approval and faster entry into the market. These flexibilities refer to the extension of redundant clinical tests, especially comparative confirmatory tests, and the exemption of animal toxicological tests, as well as the acceptance of a global referenced product having wide access to full dossier information. Although the adoption of these flexibilities has had a justified rationale since 2014, they were only partially incorporated by the World Health Organization until 2022. In Latin America region, the incorporation of flexibilities is diverse and has a low impact on the configuration of competition in the market to achieve better prices. Colombia, Brazil and Argentina have adopted a pro-competitive regulation, so did England. United States of America started this discussion only in 2023..