Comment sécuriser les traitements par les biomédicaments?

Abstract

Biopharmaceuticals represent a growing share of drug innovation. These complex biological products are derived from recombinant DNA biotechnology and are defined by their manufacturing process. Copies of these products, called biosimilars, are not identical to their princeps products and complicate the treatment choice. Minimal changes at any stage of the biopharmaceutical manufacturing process may affect safety and/or efficacy. Cases illustrating the issues surrounding the optimization of biopharmaceutical safety and efficacy include:--the biological activity and immunogenicity of erythropoietins, which depend on the expression cell system and isoform,--glucocerebrosidases with non identical structures have the same bioactivity,--interchangeability of botulinum toxins,--pharmacokinetics of insulin analogs,--protein immunogenicity. The development and interchangeability of biopharmaceuticals must be addressed on a case-by-case basis. The European authorities propose guidelines for the development and registration of biological products, with a specific approach for biosimilars. Biopharmaceutical use requires close patient monitoring and product traceability.