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FDA investigators find no safety risks when switching between biologics, biosimilars

FDA investigators find no safety risks when switching between biologics, biosimilars
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Thomasm herndonShenaz baghaBysara kellnerOffice of therapeutic biologicsTherapeutic biologics

No Differences in Safety, Immunogenicity Observed in Patients Switching to Biosimilar

Results of a recent systematic review demonstrated no difference in the immunogenicity rates and safety profiles in patients who switched to a biosimilar and those who continued to receive the reference product.

United statesThomasm herndonDrug administrationOffice of therapeutic biologicsOffice of new drugsBiologics price competitionInnovation actTherapeutic biologicsNew drugsDrug evaluation