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

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.

Development of vaccines to help treat drug dependence.

The social and economic consequences of drug addiction are immense. Although many methods are adopted to treat addiction, including therapeutic intervention and counseling, the long-term success rate has been limited and there continues to be a need for more effective treatments. A novel approach that has sparked a significant degree of interest recently is the use of vaccines designed to raise specific antibodies against drugs of abuse. Antibodies that prevent addictive substances crossing the blood-brain barrier may prove to be an effective mechanism that will help prevent relapse during efforts to abstain from the drug. Proof-of-principle for this approach has been established in numerous animal models. Currently a cocaine vaccine is in phase II clinical trials and, more recently, two vaccines to nicotine have entered phase I trials. Key efficacy trials are required to establish the true potential of these therapeutic vaccines.