Identifiability of Biologicals: An Analysis Using EudraVigilance, the European Union's Database of Reports of Suspected Adverse Drug Reactions.

The relevance of biological therapies for an increasing number of conditions is on the rise. Following the expiry of the initial period of market exclusivity, many of these successful therapies have seen the arrival of biosimilars on the market. The clear identification of the precise medicine responsible for an adverse drug reaction (ADR) report is an important element for pharmacovigilance, allowing timely detection of potential product-specific safety signals. We looked at the identifiability of biologicals up to the level of commercial product name in ADR reports received from European clinical practice between 2011 and December 2019. A good level of identification (91.5%) was observed overall, but at the same time a downward trend was observed in the last 5 years. This reduction in the level of identifiability of biological products (originators and biosimilars) at the commercial name level in general was driven by five widely used substances, whereas the identification of all other biologics stayed consistent over time (at over 90%). We observed that those five substances were used mostly within oncology. The introduction of the first biosimilar in the market did not appear to affect their identifiability. These results show that although the general level of identification at the commercial product name level in ADRs in Europe is robust and generally stable over time, decreasing trends can be down to a few commonly used substances, which need to be monitored to reverse the trend.

[Biosimilars in the European Union: current situation and challenges]. / Biosimilars in der EU: Bestandsaufnahme und neue Herausforderungen.

Biosimilars are medicinal products that are highly similar to approved biopharmaceuticals. Biosimilars enable patient access to biological therapies that would otherwise be restricted or delayed due to cost reasons. After the successful introduction of low-molecular biosimilars in 2006, highly complex monoclonal antibodies have also been available since 2013 as biosimilars for treating autoimmune diseases and oncologic indications. In principle, the biosimilar concept can be applied to all well-characterized biologicals; in the future, blood clotting factors or drugs containing nucleic acids, such as DNA or RNA gene therapy or mRNA vaccines, will also be an option for biosimilar development.In some instances, biosimilarity can be demonstrated by physicochemical and functional similarity, and additional comparative clinical efficacy and safety studies have been considered no longer necessary for several product categories in recent years. Switching a patient from a reference drug to a biosimilar or from one biosimilar to another (interchangeability) has so far been considered harmless. Since February 2020, there has been a provisional decision in Germany that patients should be switched according to an economic prescription method. Further scientific findings on the interchangeability of biosimilars and experiences with the supply practices of biosimilars should be collected and evaluated.In this article, the current situation regarding marketing authorizations of biosimilars in the European Union is reviewed. The role of clinical trials for biosimilars is presented, and challenges of biosimilar development and views on interchangeability are discussed.

Preparing for the incoming wave of biosimilars in oncology.

With the imminent arrival of oncology biosimilars in the therapeutic paradigm, stakeholders including a clinician, specialist nurse, patient advocate, regulator and economist provide their perspective on optimising the uptake of these new agents in the treatment of cancer. A number of key messages emerge, based on the discussion that took place during a session of the European Society for Medical Oncology's Annual Congress, ESMO Madrid 2017. First, for successful integration of biosimilars into the global healthcare paradigm, informing and educating the full scope of stakeholders, including clinicians, nurses, pharmacists and patients, is primordial. Success is dependent on providing solid evidence and ensuring all voices are heard. Second, for oncology medicines, much can be learnt from the growing experience of approved biosimilars in other disease indications, with success stories for patients, their healthcare providers and healthcare budgets alike. Finally, effective sustainability of the impact on healthcare budgets and the redirection of these savings require education and transparency.