The Future Potential of Biosimilars Targeting B-Cells

Abstract

AbstractThe patent and regulatory data protection periods for the first and second waves of biological agents based on recombinant proteins have started to expire, leaving open the potential for development and regulatory approval of 1 or more “similar” versions of these biologic therapies, termed biosimilars in Europe (BS)—the term that will be used in this chapter—subsequent entry biologics in Canada, or follow-on-biologics in the USA. The development of BS therapies could lead to a substantial saving for patients/health systems and, therefore, increased availability of effective treatments. BSs are similar but not identical to their reference products, because their chemical characteristics are directly related to the manufacturing process, which cannot be precisely duplicated. An exact replica of a protein molecule is extremely difficult if not impossible. Thus, major concerns about short- and long-term safety and efficacy have been raised and should be addressed in the approval process by regulatory agencies. For these reason, BSs require an approach to grant the marketing authorization, different from generics.KeywordsReference ProductQuantifiable CostPharmacovigilance ProgramEMEA GuidelineBiologics Price CompetitionThese keywords were added by machine and not by the authors. This process is experimental and the keywords may be updated as the learning algorithm improves.