But also with other drug products, e.g. polypeptides (glatiramoids), swelling polymers, liposomes as the NBCD class is growing.[1][2][3] Hence and due to their complexity and specific composition mix, such colloidal iron carbohydrate drugs cannot be fully identified, characterized, quantitated and/or described by physiochemical means to define their pharmaceutical properties. Therefore, contradictory to the generic paradigm pathway, relying on a full pharmaceutical identity and sameness in vitro evaluation exercise, they need additional (biological, in vivo) evaluation with a reference product to assess comparability e.g. in tissue targeting in the body. This requires an appropriate, yet to be defined and be harmonized regulatory approach for these new class of medicinal products.[4][5] The profile and the performance of NBCDs is defined by the multi-step manufacturing process, which is laborious, difficult to control and not disclosed by intellectual property.