The controversy around technical standards for similar biotherapeutics: barriers to access and competition?

摘要

Technical standards for medicines' marketing authorization are technical issues. Nonetheless, policy, political and commercial matters also play a role. Given that technical standards impact competitor's market entry pace and prices, regulators are compelled to strike a balance between access, safety, and quality,1 determine which standards are necessary to protect human health and tear down unnecessary barriers to competition. There is a consensus that generic medicines can be approved via "abbreviated pathways". However, for biotherapeutics, there is an ongoing global controversy as to whether the abbreviated approach is also applicable. It evolves as emerging evidence about safety and efficacy of biosimilars gets published. We identified three types of regulatory barriers to competition. Here we propose a conceptual approach to analyze them. The triangle illustrates the rationale behind the debates around the regulatory requirements for biosimilars and the impact of those requirements on access (Figure 1).