Quality Defects

The European Medicines Agency has acknowledged and published specific guidelines regarding efficacy, safety and quality for the development of biosimilar products.

Biological medicinal products (BMPs) are increasingly used to treat diseases such as multiple sclerosis, various autoimmune disorders and cancers. Biosimilar medicines are follow-on versions of original BMPs (they are independently developed after the patent protection of the original product has expired). Biosimilar medicines are intended to have the same mechanism of action as the original BMPs, and are designed to treat the same diseases as the innovator products. However due to the complex structure and intricate manufacturing processes of large molecular weight protein macromolecules, they can only be considered “similar” to the original product unlike the generics of chemically similar molecules. It is not possible to produce direct molecular copies or ‘generic’ equivalents, because of the complex molecular structure of these molecules. The European Medicines Agency has acknowledged this issue and published specific guidelines regarding efficacy, safety and quality for the development of biosimilar products.


In 2013 two Infliximab biosimilar monoclonal antibodies (Remsima/Inflectra ) were authorised in the EU. It is widely expected that the number of biosimilars authorised in the EU will increase significantly in the coming years and such products will likely become more widely used in Ireland and elsewhere. The standards for quality, safety and efficacy for biological medicines products are very complex and it is essential that healthcare professionals involved in their clinical use and supply are appropriately informed on these unique characteristics. Particular areas of focus will include safety concerns associated with inter-changing biosimilar substances, enhanced pharmacovigilance and traceability requirements and the need for procurement/purchasing procedures to take due account of the difference of biosimilars relative to the innovator products.


HPRA togeter with UCC have establised a project a to conduct research on the public health impact of increased use of biosimilars. This project is also supported by the Irish Pharmaceutical Healthcare Association (IPHA). The output from this research is intended to inform and drive both the development of national guidelines from HPRA on biosimilars and to assist in identifying and implementing mechanisms to achieve increased understanding of health care professionals, patients, healthcare providers and policy makers involved in the use of these medicinal products

In spite of recent developments with new science and risk based regulatory guidance with a focus on both Quality Risk Management and the overhaul of Pharmaceutical Quality Systems, there has been an increasing trend in serious quality defects occurring in medicinal products being reported from the marketplace and being identified at manufacturing sites.


HPRA together with the EMA (through the EEA Rapid Alert network) have identified an opportunity to carry out a pan-European research project on Quality Defects and Product Recalls, with a view to identifying trends and key learning's from the extensive quality defect and recall data that are currently available.


HPRA together with DIT and PCI have established as research study which aims to develop a ‘proof of concept’ report to support initiation of the pan-European project. It also seeks to establish a common taxonomy for quality defects and recalls to inform the design of the future pan-European project for implementation across a number of National Competent Authorities (NCAs).