The rise of bio- and nano-technologies has accelerated the development of complex drug products, a class of products that include – but are not limited to – Non-Biological Complex Drugs (NBCDs). NBCDs, e.g. glatiramoids, iron-carbohydrate complexes, polymeric micelles, complex ocular emulsions and liposomes, consist of different (closely related and often nanoparticulate) structures that cannot be fully quantitated and characterized by physicochemical analytical means. The complex nature of NBCDs means that minute variations in the manufacturing process can substantially change the composition of final products, and this poses a challenge for the development of regulatory guidelines. While guidance for developing generic versions of small molecule drugs is well established, and progress has been made for biological complex drugs, there is very little guidance for follow-on versions of NBCDs. This is further complicated by the difficulty of aligning strategies of international regulatory bodies due to their different legal frameworks. To advance research and build consensus, it is necessary to engage together key stakeholders from academia, regulatory bodies, industry and drug manufacturing.

To stimulate this discussion, the above-mentioned organizations present this one-day conference: Equivalence of Complex Drug Products: Scientific and Regulatory Challenges. This convening aims to identify the best approaches for complex drug development and regulation, to outline outstanding challenges in the assessment of complex drug equivalence and consequences for interchangeability of products, to address whether the regulatory approaches for biosimilars should be used as models for other complex drugs, and to clarify differences and commonalities in the behavior of biological and NBCD families. The end goal is to facilitate the translation of scientific findings into advancements in medicine and to ensure the safety and benefit of patients.

Full details of this conference, including the programme and speaker details, can be found on: www.nyas.org/ComplexDrugs16

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