United States

Amphastar’s leadership has discussed its strategy and latest results as part of a fireside chat at this year’s Jefferies Healthcare Conference, restating its expectations of potential approvals of its GLP-1 candidate in 2025.

At the recent Jefferies Global Healthcare Conference in London, Sandoz’s CEO Richard Saynor colorfully shared the firm’s dreams and achievements, and the market’s current state of play.

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. Meanwhile, competition to Stelara is waiting in the wings from the start of 2025.

When the agency decided biosimilarity standards would be high, it likely ensured the interchangeability designation eventually would become unnecessary.

A new, international group of health technology assessment agencies will work together on topics related to health economic methods that could include dynamic pricing and non-traditional ways of evaluating value in cost-effectiveness analyses.

MSN Laboratories has struck a patent-litigation settlement deal with BeiGene that will allow it to launch its zanubrutinib generic rival to Brukinsa in the US from 2037.

Removing the patent-protected indication from the label of Norwich Pharmaceuticals's proposed generic for Xifaxan did not convince the US Supreme Court to hear its petition to review a case from Bausch Health that blocked approval until 2029.

The US Supreme Court has failed to come to the aid of Norwich Pharmaceuticals in its legal battle over a generic version of Xifaxan (rifaximin) that has a patented indication carved out of its label. An earlier decision over the generic thus bars approval and launch until 2029.

As China faces the potential loss of a big customer base, the US off-patent industry starts to look for new relationships elsewhere. While building domestic manufacturing capabilities would be the ultimate American dream, the government has yet to offer the carrot, not just the stick.

The pharma industry arguably suffered none of the downside risks that were possible during the first Trump administration, and their relationship with Biden could not have gone much worse. And while they may hope a Trump return could help their fortunes, having RFK Jr. supervising the FDA is likely not the prescription they want.