In a recent study published in Plos One, researchers conducted a systematic review and meta-analysis employing statistical methods to ascertain if there were safety outcome variances between individuals who switched between a biosimilar and a reference product and those who did not switch.
The findings of this FDA-conducted study were discussed on the FDA website. The authors noted that the researchers concentrated on any statistical variances in the number of mortalities, nonfatal serious adverse events, and study terminations due to an adverse event. The researchers also examined and compared data following switching for events with regard to immunogenicity.
The authors noted, “Among the 44 identified switch time periods (STPs), 28 had a single switch and 16 had multiple switches within the STP time period. Altogether, the studies evaluated 21 biosimilars corresponding to eight different reference products. This translates to 5,252 participants who underwent at least one switch and 5,770 individuals who served as no-switch controls.”
In the meta-analyses, there was zero variation in the risk of mortality, serious adverse events, and termination of treatment among participants who switched between biosimilars and reference products and participants who did not switch. Additionally, immunogenicity data revealed comparable incidences of antidrug antibodies and neutralizing antibodies in individuals who switched and individuals who did not switch. Among participants in switched and nonswitched groups, immune-related adverse events such as anaphylaxis, hypersensitivity reactions, and injection site reactions were analogous.
Based on these data, the researchers concluded that there were no distinctions in the risk of mortality, serious adverse events, or treatment discontinuations between the switch and no-switch arms.
The authors noted, “These results were not affected by the reference product class, the direction of the switch (reference product to biosimilar or vice versa), or the number of switches (single switch vs. multiple switches).”
The authors also indicated that their findings aligned with previously published nonstatistical descriptive reviews of switching biosimilars and provided additional evidence for patients and their healthcare providers that switching between biosimilars and their reference products is not correlated with significant safety events.
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