Biologicals and biosimilars: safety issues in Europe.

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.

O ciclo de valor e o preço dos medicamentos / Value cycle and pricing of pharmaceuticals

Resumo Desde o acesso ao mercado até o termo da comercialização, os medicamentos percorrem ciclos de valor, que são aferidos pelo desempenho de variáveis endógenas e exógenas ao medicamento. Os ciclos de valor constituem intervalos de tempo durante o qual o valor se mantém constante. A definição do preço dos medicamentos deve ter lugar em função do valor observado em cada ciclo. O contrato como instrumento de regulação das relações jurídicas administrativas com os titulares das autorizações de utilização de medicamentos, dispositivos médicos e outras tecnologias de saúde compromete-os com os objetivos do sistema de saúde em que se inserem, enquadrando as condições de comparticipação ou aquisição mediante avaliação prévia.

Abstract From access to term of marketing, medicines go through value cycles measured by the performance of endogenous and exogenous variables. Marketing access includes efficacy, safety profile, and therapeutic indications, whereas term of marketing comprises drug life cycle and public health priorities. The value cycles are time intervals during which the value is constant. The setting of the price of pharmaceuticals should occur according to the value observed in each cycle. A system of pricing based on value cycles is dynamic, transparent, and geared towards efficiency and sustainability. Agreement as a regulatory tool of administrative and legal relationship with the marketing authorization holder is committed to the goals of the health care system.