Non-biological complex drugs

Medicines that are not manufactured using biotechnology

Non-biological Complex Drugs (NBCDs) are medical compounds that cannot be defined as small molecular, fully identifiable drugs with active pharmaceutical ingredients. They are highly complex and cannot be defined as biologicals as they are not derived from living materials. NBCDs are synthetic complex compounds and they contain non-homomolecular, closely related molecular structures with often nanoparticular properties. This is, for instance, the case with the iron sucrose and its similars. But also with other drug products, e.g. polypeptides (glatiramoids), swelling polymers, liposomes as the NBCD class is growing. 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 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. 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. Minimal changes in for instance the starting materials or the process conditions might result in significant clinical differences affecting therapeutic effects or safety.

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