Is the local tolerance of injectable biosimilars too underestimated?

Category: Editorial
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The previous issue of GaBI Journal included the publication of an article on the “Systematic analysis of injection-site pain and reactions caused by subcutaneous administration of the adalimumab biosimilar FKB327 versus the adalimumab reference product via different delivery methods,” by Alten et al. [1]. The topic of this article is of importance as there are very few biosimilar evaluations devoted to minor side effects. As with new molecules, the published clinical trials of biosimilars mainly focus on major side effects, such as haematological, cardiac, or neurological disturbances. As a result, effects without major clinical consequence, from the medical practitioner’s point of view, such as pain during injections, low intensity itching or even slight fatigue, are poorly reported and thus underestimated. This is even more evident in the clinical trials requested for the registration of a biosimilar. However, these effects often cause discomfort for patients and can play a fundamental but poorly evidenced role in the acceptability of the biosimilar and in the prescriber’s willingness to use it. If a biosimilar, especially those authorized by the European Medicines Agency (EMA) or the US Food and Drug Administration (FDA), is, by definition, highly comparable to its originator, the two drugs should have identical tolerability. This is obviously true for major side effects but is open for debate when it comes to local tolerance during injection. In fact, the composition of the excipients may vary between formulations, and the quality of packaging, such as needles, may induce different local reactions.

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