Biologicals and biosimilars: safety issues in Europe

M.D.C. Portela*, C. Sinogas, F.A. de Almeidad, R. Baptista-Leite, A. Castro-Caldas

*Corresponding author for this work

Research output: Contribution to journal(Systematic) Review article peer-review


Introduction: Medicinal products of a biological origin are approved by the EMA at a centralized level. However, there is no harmonization about their use in Europe. The current regulation referring to the safety of biological medicinal products and biosimilars in Europe has been identified. The safety associated with medicinal products of a biological origin is assured by the pharmacovigilance system, which has evolved, but doesn't yet incorporate all of the specific information from this market segment, namely that related to the identification of drugs, and its use - including the prescription and dispensing, given the possibility of interchangeability and substitution. The terminology, information systems and traceability systems aren't entirely appropriate to ensure the safety requirements for therapy with medicinal products of a biological origin.Areas covered: This article aims to identify the prescription and dispensing profiles of reference biological medicines and biosimilars in the EU, and the determinants that support their safe use.Expert opinion: The European pharmacovigilance system must evolve to ensure the safety along all of the biologicals' therapeutic cycle. It must consider the safety for each of the medicines in addition to their safety pattern related to the eventual switching procedure.
Original languageEnglish
Pages (from-to)871-877
Number of pages7
JournalExpert Opinion on Biological Therapy
Issue number7
Publication statusPublished - 2017


  • Biologicals
  • biosimilars
  • pharmacovigilance
  • safety
  • substitution
  • interchangeability


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