The sprawling safety surveillance system is propelling advances in informatics and advanced analytics, but the agency is delaying next contracting cycle to digest its experience.

The launch of competition to Humira was the main event for US biosimilars this year – but a number of other key developments also took place in 2023, including settlements on Stelara that set up a series of launches in 2025, as well as first approvals for ustekinumab, natalizumab and tocilizumab biosimilars.

Organon has reduced its full-year revenue expectations following a number of headwinds, including lower-than-expected uptake of its adalimumab biosimilar.

Otsuka steps into the ocular gene therapy field through a technology licensing deal worth up to $1.5bn with ShapeTX, which in turn further expands the US firm's global reach following a $3bn collaboration with Roche.