Eleni Taoula: Complex global regulatory landscape for ADCs

Eleni Taoula, Associate Professor at The University of Nicosia Medical School, shared on LinkedIn: 

“ADC drugs have seen rapid development from 2017 to 2020. The FDA has been at the forefront, approving 13 ADCs since 2011, while the EMA has approved 9, often following FDA approvals but sometimes with different indications or timing.

In China, the NMPA has been more selective, approving 4 ADCs to date. Notably, in January 2020, T-DM1 (Genentech and Roche) was approved by the NMPA, marking a significant milestone in China’s ADC drug development.

This staggered approval process across regions reflects varying regulatory standards, clinical data requirements, and market access strategies for ADCs worldwide. While there’s general alignment in ADC approvals among these regulatory bodies, notable differences exist:

– The FDA often leads with accelerated approvals, allowing earlier patient access.
– The EMA sometimes grants broader indications or requires additional data.
– The NMPA’s approvals often come later but include locally developed ADCs, reflecting China’s growing biotech capabilities.

These variations highlight the complex global regulatory landscape for ADCs and the importance of tailored development and registration strategies for each major market.

The below image highlights a timeline by which ADC drugs have been approved.”

Source: Eleni Taoula/LinkedIn