title: EU's new pharmacovigilance legislation: considerations for biosimilars.
abstract: Biosimilars are biological medicines, the active substances of which are highly similar to those of biologics that have already been authorized. As for any other medicine, the applicant of the biosimilar marketing authorization must submit a risk-management plan (RMP)/pharmacovigilance plan. The pharmacovigilance plan should take into account risks identified during product development, the potential risks and how those risks will be addressed after authorization of the product.Recently, new European Pharmacovigilance legislation has been implemented, ensuring proper risk management through the recording of suspected adverse drug reactions and data collection from all stakeholders. The new regulation entails a reduction of the administrative burden on companies and regulatory agencies, as obligations of the responsible parties are clearly established and duplication of effort avoided.This article analyzes the new European Pharmacovigilance System requirements, with special focus on those medicines requiring additional monitoring, such as biosimilars, which are priorities for pharmacovigilance. Further, it provides the new obligations to marketing authorization holders, such as the continuous benefit-risk assessment.
authors.affiliation: Pharmaceutical Technology Department, Faculty of Pharmacy, University of the Basque Country, P. Universidad, 7, 01006, Vitoria-Gasteiz, Spain, b.calvo@ehu.es.
authors.forename: Begoña
authors.initials: B
authors.lastname: Calvo
authors.forename: Leyre
authors.initials: L
authors.lastname: Zuñiga
mesh_terms: D001688:Biological Products / Q000009:adverse effects / Q000627:therapeutic use; D059451:Biosimilar Pharmaceuticals / Q000009:adverse effects / Q000592:standards* / Q000627:therapeutic use; D064420:Drug-Related Side Effects and Adverse Reactions; D005062:European Union; D006801:Humans; D007880:Legislation, Drug; D060735:Pharmacovigilance; D018570:Risk Assessment / Q000331:legislation & jurisprudence; D012308:Risk Management / Q000331:legislation & jurisprudence
chemical_list: D001688:Biological Products; D059451:Biosimilar Pharmaceuticals