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Analysts hold back on predicting new heights for B+L until full split from parent firm. It reported Q4 revenue up 9% to $1.28bn and full-year revenue up 16% to $4.79bn.

Generics Bulletin reviews the latest regulatory developments across the world.

Alvotech has followed its European filing for a biosimilar to Regeneron’s Eylea (aflibercept) 2mg with acceptance for review from the US Food and Drug Administration for its AVT06 candidate.

In an update to its strategy for dealing with US tariffs, Korea’s Celltrion has revealed actions taken so far, as well as outlining plans to consider moving “swiftly” to secure US manufacturing for APIs if circumstances demand.

Along with its 2024 full-year and fourth-quarter results – both down slightly – the Los Angeles-based firm on 19 February announced its board appointed Stephan Gratziani, president since January 2024, as CEO effective 1 May.

While quarterly revenues show ups and downs in each region, Lupin is set on continued growth, with a touch of complexity and innovation – including shifting its thinking on the attractiveness of biosimilars.

Jim Jones, the head of the FDA's food programs, resigned due to widespread layoffs at the agency imposed by the Trump administration’s Department of Government Efficiency.

As many as 700 employees reportedly dismissed from posts starting on 14 February as the culling of the federal workforce by the Trump administration’s Department of Government Efficiency reaches FDA.

Jim Jones resigna due to widespread layoffs at the agency the Trump administration’s Department of Government Efficiency imposed.

"While we mourn his passing, we also celebrate his remarkable legacy, which will continue to shape AHPA and the broader industry for years to come,” AHPA says.