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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

American Journal of Clinical Nutrition 32:25865

The proposal reflects a recognition that cash-pay models have limited impact when they exist outside the insurance system