Originators query switching

One interchangeable biosimilar should not be substituted for another in the US, and US Food and Drug Administration (FDA) guidance should reflect that, several biologics originators argued during an FDA public hearing on biologic competition and innovation. The same point was echoed by the originator-backed Alliance for Safe Biologic Medicines (ASBM).

AbbVie’s Nathan Doty described switching between interchangeable biosimilars of the same reference brand as “not scientifically justifiable” due to structural differences that could “induce immunogenicity when patients are switched between...