Biosimilars: The French policy

Issue title: Biologicals – Pharmaceuticals, Blood Products and Vaccines

Article type: Research Article

Authors: Schück, Stéphane | Texier, Nathalie

Affiliations: Kappa Santé, Paris, France

Note: [] Address for correspondence: Stéphane Schück, Kappa Santé, 21 rue de Turbigo, 75002 Paris, France. E-mail: [email protected].

Abstract: The future of the pharmaceutical industry lies with biotechnology. Biological drugs are complicated, expensive products used to treat complex conditions but their contributions to public health are important. A number of biopharmaceuticals on the market have seen their patent protection expired which led to the development of biosimilars. Biosimilars are embedded in the field of biotechnology and their use in therapeutics raise some questions with respect to their safety because of complex production methodologies. This paper summarizes the French law regarding the safety and the development of such drugs.

Keywords: Biosimilars, safety, pharmacovigilance, French law

DOI: 10.3233/JRS-2009-0458

Journal: International Journal of Risk and Safety in Medicine, vol. 21, no. 1-2, pp. 41-45, 2009