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FDA Meta-Analysis Concludes Biosimilars are Interchangeable

Oct 3, 2023

An FDA meta-analysis found that there are no differences in safety profiles or immunogenicity rates in patients who switched to biosimilars compared to those who remained on an originator biologic or biosimilar.  Biologics assessed in the study include adalimumab, epoetin alfa-epbx, etanercept, filgrastim, infliximab, insulin glargine, rituximab, and trastuzumab.  

On 18 September 2023, the FDA released its draft industry guidance for biosimilar and interchangeable biosimilar product labelling.