US FDA Generic Drug Approvals, Other Actions Declined As Approval Times Climbed In FY 2024
An increase in complex product submissions may explain median and mean approval time increases for ANDAs, but fewer actions across many categories could be a concern.
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Generics Bulletin reviews the latest regulatory developments across the world.
Unleashing a trio of major announcements, Formycon has indicated a gloomy outlook for US Stelara biosimilar pricing; revealed plans to pause commercialization of its Sandoz-partnered US Cimerli rival to Lucentis amid discounting from rivals; and set out ambitious plans to win FDA approval for its proposed Keytruda biosimilar without any Phase III data.
Discussing a new report highlighting the lack of US biosimilar competition on the cards for the majority of biologics losing exclusivity in the next ten years, the AAM’s Access! 2025 conference heard that the “sobering” findings should act as a “wake-up call for stakeholders.”
Trump’s former FDA commissioner sees ‘nothing good’ coming from negotiating a new user fee agreement in the ‘current political environment.’
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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.
With sales remaining sluggish, on the back of fewer launches, Glenmark’s management nevertheless struck an upbeat tone when discussing the firm’s prospects in the US moving into the company’s 2026 financial year.
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.