Mission (im)possible? Efficient Global Antibody Drug Conjugate Product Approvals

The growth in Antibody Drug Conjugate (ADC) products hitting the market, including those following recent approvals in 2025 in Japan and China brings into sharp focus the importance of the regulatory strategy, especially considering that the global regulatory framework for ADCs has been in a state of evolution.

- By Dr Eilidh Mayer, Regulatory Strategy Director, ICON

ADCs are highly complex molecules that were initially developed to allow highly potent cytotoxic agents to be selectively delivered to cancer cells by way of antibodies that find and bind to a specific antigen on cancer cells. The therapeutic payload is attached to the antibody using a linker, which ensures the payload is not released until once inside the target cell. The combination of these three components requires careful consideration as altogether they span both biologics and small molecules across a broad range of guidelines, including ICH. Some regulatory agencies have developed ADC-specific guidelines, for example the US FDA's Clinical Pharmacology Considerations for Antibody-Drug Conjugates Guidance and China NMPA's Technical Guidance for Antibody-Drug Conjugates, though as yet, these are not mirrored across health authorities in all regions, and addressing national nuances in global development of ADCs remains challenging.