BioPharmaceutical

Following steady updates on its development of a new formulation of valacyclovir, Hyloris revealed the US FDA’s acceptance of its NDA filing while also announcing three new deals this month.

Following on a slew of approvals in the past year, Henlius announced the first overseas approval of its Avastin biosimilar in Bolivia where it is partnered with the Brazilian firm Eurofarma.

A new US presidential administration brings both challenges and opportunities for the off-patent industry. Speaking to Generics Bulletin on the sidelines of the AAM’s annual conference earlier this month, the association’s chair and Sandoz North America president Keren Haruvi discusses how the group plans to make its voice heard on key priorities including tariffs, PBM reform, and regulatory streamlining.

Two recent disclosures from Xbrane Biopharma and Formycon demonstrate how the US Food and Drug Administration’s thinking is evolving on the necessity of Phase III trials to support biosimilar filings.

Select Indian drug manufacturers have missed some analyst estimates while Japanese firms continue in their efforts to leave the country’s generic drug supply crisis in the past.

The same day as Samsung Bioepis and Sandoz launched their partnered Pyzchiva biosimilar rival to Stelara in the US, originator J&J hit the Korean developer with a lawsuit claiming that a private-label commercialization deal with a US pharmacy benefit manager violates the ustekinumab settlement that allowed the firms to launch.

During Q4, biopharma merger and acquisition deal value reached $9.4bn and drew in $72.8bn in potential deal value from alliances. Device company M&A values reached $395m, while in vitro diagnostics and research tools players’ M&A activity totaled $604m.

The UK’s NHS and Sandoz have both told Generics Bulletin that they are looking into reports from a single UK hospital of adverse reactions linked to patients that have switched from Tysabri to Sandoz’s Tyruko biosimilar.

As more Stelara biosimilars pile into the US market – including launches from Alvotech/Teva, Samsung Bioepis/Sandoz and Biocon Biologics – the latest data suggests that price competition for ustekinumab rivals could be fierce, with all three companies confirming to Generics Bulletin details of significant discounts to the brand.

The International Generic and Biosimilar Medicines Association has introduced its first global intellectual property and competition report, addressing the urgent need to reform current regulations. But, in a bid to increase access to medicines across the world, did it stop short at just IP and patents?