Generics Bulletin Perspectives

Generics Bulletin looks back at a selection of the most significant legal stories from 2024, including a surprising outcome in biosimilars, a major small-molecule generic opportunity, and a flurry of activity over GLP-1s.

We review the most notable regulatory developments of the past year, with experts outlining for Generics Bulletin the regulatory to-do list for 2025.

US biosimilar competition to Stelara is waiting in the wings from the very start of 2025. But with seven ustekinumab rivals already approved by the FDA and set to launch, how will things shake out in such a crowded market? Generics Bulletin looks at the contenders.

GLP-1 drugs like Ozempic and Mounjaro have shaken up pharma, crossing firmly over into the mainstream while netting fortunate suppliers billions of dollars in the process. As patent expiry approaches for first- and second-generation products, generics manufacturers are gearing up to take a share of the spoils.

This year, regulators questioned the US interchangeability designation and the need for comparative efficacy trials, while finding ways to promote biosimilar development and accessibility. Will this momentum continue in 2025? Generics Bulletin spoke to experts from across the industry to hear their views.

Generics Bulletin's editorial team discusses key topics from the year, including the latest rankings of the Generics Bulletin Top 50, Amgen’s surprise launch of a US Eylea biosimilar, the EU’s Urban Waste Water Treatment Directive and supply-chain issues for the off-patent sector.

As the US biosimilars market approaches the end of its first decade, it has seen another busy year, with Amgen’s surprise launch of a rival to Eylea shaking up expectations as other first-time approvals rolled in throughout 2024.