GETTY reference product must be proven in the initial indication in clinical studies
• immunogenicity data derived from a clinical study in the initial indication are evaluated regarding patient- , disease- and treatment-related factors in the extrapolated indication . 2
Generally , after a thorough evaluation of the submitted data , biosimilars are approved for the same indications as the RPs , except where patent protection exists .
Pharmacovigilance and traceability The safety of biosimilars is monitored in the European Union ( EU ) through pharmacovigilance activities , in the same way as for any other biologic medicines . The application for marketing authorisation must be accompanied by a risk management plan ( RMP ) that must include a pharmacovigilance plan and risk minimisation measures to identify , characterise and minimise the product ’ s important risks . 2 Additional measures such as educational materials , patient alert cards , inclusion of details in a patient registry or implementation of a post-authorisation safety study are also required as part of the approval and mandatory to implement by the company holding the license . The RMP of a biosimilar is based on knowledge and experience with the RP and safety measures applied to the RP are also considered for the biosimilar by the regulation authorities . 2
It is also common practice for companies to collect spontaneous reports of adverse drug reactions and submit periodic safety update reports ( PSURs ). 2 Because a biosimilar represents a new active substance , clinical use should be
monitored closely during the first year of approval and the package leaflet labelled with the black triangle . The black triangle should raise awareness among patients and physicians of the need for additional monitoring and encourage reporting of suspected adverse drug reactions . 2
Product and batch documentation are important for traceability of all biologics through the entire distribution chain until administration to the patient . 6 Correct identification of the products administered requires documentation of tradenames and batch numbers in the patient ’ s healthcare record . However , in cases where automatic substitution it permitted , this can make traceability and identification in the pharmacovigilance report more complicated .
Key regulatory guidelines for development of biosimilars Europe and the UK The European Medicines Agency ( EMA ) was the first medicines agency worldwide to implement a regulatory framework for the development and authorisation of biosimilars . Since 2004 , biosimilar guidelines have been implemented to provide transparency on the requirements for approving biosimilars and to help applicants to conform with the requirements . 2 The initial overarching guidelines addressing quality , non-clinical and clinical issues were followed by product specific guidelines addressing the specific clinical issues of the different type and mechanism of action of the different biologics encompassing various molecules acting as growth factors , hormones , and cytokines ( summarised in Table 1 ). Of note , there is only one guideline addressing the non-clinical and clinical issues of
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