Safety Issues of Biosimilar Products

What is it about?

Despite the undeniable advantages of such procedure, some concerns (such as the absence of switching studies or the evaluation of efficacy and safety in all therapeutic indications) still exist about it. In particular, the European regulatory framework on biosimilars approval does not include the conduction of switching studies demonstrating the interchangeability to be carried out before marketing authorization. This is one of the main aspects that negatively affects healthcare professionals' clinical decisions on switch. The FDA has accepted the concept of extrapolation of indications; we just need additional high-quality research on non-medical switching and the risk of immunogenicity. FDA recently released a white paper indicating the types of trial designs that would be required before nonmedical switching of biosimilars in stable patients could be endorsed—in distinction to substitution by a pharmacist in patients starting therapy. These types of trials would involve multiple crosses between an originator biologic agent and a biosimilar. Thus, we need more studies on switching, especially multiple-switch studies

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Photo by David Rotimi on Unsplash

Photo by David Rotimi on Unsplash

Why is it important?

It is important to be clear about whether a specific product has been evaluated through a rigorous evaluation procedure based on the criteria defined in the EMA, FDA, or WHO biosimilar guidelines. It is also important for prescribers to understand what happens when a particular biosimilar receives a designation of ‘interchangeable’ with the originator and when substitution may occur, as these designations/ policies may impact patient outcomes.