Current state of biologic pharmacovigilance in the European Union: improvements are needed

ABSTRACT

Introduction: Pharmacovigilance is essential to monitoring the safety profiles of authorized medicines. Compared with small-molecule drugs, biological drugs are more complex, more susceptible to structural variability due to manufacturing processes, and have the potential to induce immune-related reactions, underscoring the importance of safety monitoring for these products. Although highly similar to reference products, biosimilars are not expected to be structurally identical. For these reasons, proper reporting of potential adverse drug reactions (ADRs) using distinguishable names and batch numbers is essential for accurate tracing of all biological drugs. To address the need for robust pharmacovigilance, the European Parliament and Council of the European Union provided legislation regarding pharmacovigilance of biologics in 2010.

Areas covered: This narrative review examines the current state of pharmacovigilance for biologics in the European Union (EU) and discusses relevant information on pharmacovigilance of biosimilars, the current EU pharmacovigilance system, and areas that could be improved.

Expert opinion: Although steps have been taken to improve pharmacovigilance of biologics in the EU, several enhancements can still be made, including additional training for healthcare professionals on ADR reporting, the use of 2D barcodes that enhance traceability, and an open discussion of potentially missed opportunities in the pharmacovigilance of biosimilars.

KEYWORDS:

• Adverse drug reactions
• biopharmaceuticals
• biosimilars
• pharmacovigilance

Article highlights

• Biosimilars are highly similar to, but not exact copies of their reference products.

• Given the potential for immunogenicity, special considerations are necessary with respect to pharmacovigilance of biologics, including biosimilars.

• The European Commission (EC) has provided legislative guidance to the European Medicines Agency (EMA) and EU Member States on requirements for filing adverse drug reaction (ADR) reports for biologics.

• Inconsistencies and shortcomings exist in several Member States’ pharmacovigilance systems, such as incomplete brand name and batch number reporting for biologics.

• Some EU Member States have implemented changes to their existing pharmacovigilance systems to comply with the legislation and to help address these inconsistencies and shortcomings; however, improvements are still needed.

• The EMA is working to actively improve pharmacovigilance in the era of biosimilars through initiatives such as the falsified medicines directive and SCOPE (Strengthening Collaboration for Operating Pharmacovigilance in Europe).

This box summarizes key points contained in the article.

Acknowledgments

Medical writing support was provided by Miranda Tradewell, PhD, and James Balwit, MS, CMPP (Complete Healthcare Communications, LLC, North Wales, PA, an ICON plc company), whose work was funded by Amgen Inc.

Declaration of interest

TF, JBJ, and PB are employees of, and own stock in, Amgen Inc. CA was an Amgen employee when this work was initiated. The authors 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.

Reviewer disclosures

Peer reviewers on this manuscript have no relevant financial or other relationships to disclose.

Additional information

Funding

This work was supported by Amgen Inc.