Indian firms accounted for over 50% of prescription volumes in five of the top 10 therapy areas in the US in 2022, as also 15% of the volume share of biosimilars, delivering savings and widening patient coverage a study by IQVIA said, while also highlighting supply chain risks that need attention.

The ranks of B7-H3-targeting antibody-drug conjugates under development in China have seen their first dropout, although elsewhere there are two FGFR2b-directed ADCs with first-in-class potential on the horizon. Meanwhile, there have been other discontinuations of KRAS G12C inhibitors and anti-BCMA CAR-T cell therapies in the country, while new players have surfaced in the areas of mRNA cancer vaccines and amyloid-beta-targeting antibodies for Alzheimer’s disease.

The FDA would only withdraw a rare disease gene therapy for “pretty clear” reasons, such as when there is minimal benefit with extensive side effects. The one-and-done nature of administration also makes withdrawal easier, CBER Director Peter Marks says.

Leveraging the biotech entrepreneurial spirit and global pharma resources is a win-win situation in the race to bring meaningful medicines to patients.