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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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.
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.”