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However, as we discuss, neither compound can be legally sold in the U.S

There are also some so-called pseudo-cereals, not belonging to the Gramineae family, which include quinoa, buckwheat, and amaranth, all gluten-free [138]

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Potential clinical consequences include: Development of anti-drug antibodies (ADAs) Reduced therapeutic efficacy Altered pharmacokinetics Injection-site reactions or systemic hypersensitivity Regulators therefore place strong emphasis on impurity profiles that could increase immunogenic potential beyond that of the Reference Listed Drug (RLD) Impurity Attributes That Increase Immunogenic Risk Not all impurities pose equal immunogenic concern