EU’s New Pharmacovigilance Legislation: Considerations for Biosimilars

Abstract

Biosimilars are biological medicines, the active substances of which are highly similar to those of biologics that have already been authorized. As for any other medicine, the applicant of the biosimilar marketing authorization must submit a risk-management plan (RMP)/pharmacovigilance plan. The pharmacovigilance plan should take into account risks identified during product development, the potential risks and how those risks will be addressed after authorization of the product.Recently, new European Pharmacovigilance legislation has been implemented, ensuring proper risk management through the recording of suspected adverse drug reactions and data collection from all stakeholders. The new regulation entails a reduction of the administrative burden on companies and regulatory agencies, as obligations of the responsible parties are clearly established and duplication of effort avoided.This article analyzes the new European Pharmacovigilance System requirements, with special focus on those medicines requiring additional monitoring, such as biosimilars, which are priorities for pharmacovigilance. Further, it provides the new obligations to marketing authorization holders, such as the continuous benefit-risk assessment.

Safety Profile of Biological Medicines as Compared with Non-Biologicals: An Analysis of the Italian Spontaneous Reporting System Database

“…Therefore, careful monitoring of the safety of biologicals for each specific batch and brand name is needed in clinical practice. Consequently, to ensure traceability and robust post-marketing assessment of biological products, European regulatory authorities encourage clinicians to report ADRs concerning biological products by specifying the exact brand name and batch number [20].…”

Pharmacovigilance

“…Accurate reporting of ADRs regarding the use of biologicals is especially challenging because of the restrictions in clinical trials, sensitivity to changes in the manufacturing process, the reporting of batch numbers and the establishment of valid causality assessments . First, biologicals have distinctive features that can cause ADRs and might not be detectable in conventional clinical trials (Calvo and Zuňiga 2014) . For biologicals, data from clinical trials are quite limited due to various factors, including their sample size and duration .…”

Biosimilars: Are They Bioequivalent?

“…As physicians who have cared for IBD patients for many years, we would like to have direct clinical evidence obtained in CD and UC patients, with the focus on PK, immunogenicity and safety. Pharmacovigilance can be the adequate response for some issues [19], safety or immunogenicity for instance, but clinical trials would be desirable to obtain high-quality information on efficacy, without the inherent bias of observational studies.…”