Biologicals and biosimilars: safety issues in Europe

ABSTRACT

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.

KEYWORDS:

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

Article highlights

• Biologicals and biossimilars have centralized approval by EMA

• Switching (interchangeability and substitution) is regulated by Member States

• Safety assessment of biologicals relies on pharmacovigilance data both pre-and post marketing

• The pharmacovigilance system oversees each drug’s benefit-risk assessment

• Potential risks related to switching are not adequately assessed in Europe due to the absence of specific safety tools

This box summarizes key points contained in the article.

Acknowledgments

The authors are grateful to Rita Henriques from the University of Lisbon for her support on the selection of papers. Language editing was performed using the Taylor & Francis Editing Service.

Declaration of interest

The authors are supported by Roche Farmacêutica Química LDA and the Universidade Católica Portuguesa. They have no other relevant affiliations or financial involvement with any organization or entity with a financial interest in or financial conflict with the subject matter or materials discussed in the manuscript. This includes employment, consultancies, honoraria, stock ownership or options, expert testimony, grants or patents received or pending, or royalties. Writing assistance was utilized in the production of this manuscript and funded by Roche Farmacêutica Química LDA.

Additional information

Funding

The manuscript is funded by Roche Farmacêutica Química LDA and the Universidade Católica Portuguesa.