The FDA has opened registration for a public meeting on reauthorizing the Biosimilar User Fee Act, for fiscal years 2023 through 2027.
Registration is now open for a live virtual public meeting on reauthorizing the US Biosimilar User Fee Act that will take place on 19 November.
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Sandoz has struck a deal worth up to $301m with Henlius giving it rights to a proposed ipilimumab biosimilar to Yervoy in countries across the world.
With discounts reaching up to 90%, ustekinumab biosimilars have eroded originator Stelara’s sales as expected. In its latest quarterly biosimilar market report, Samsung Bioepis also analyzed the latest regulatory steps to streamline biosimilar development.
Amid several insights into its expectations of biosimilar competition in 2025, Roche has confirmed the total amount it anticipates being shaved from its top line this year.
With the Global Generics & Biosimilars Awards 2025 taking place in Frankfurt this October, we bring you five key pieces of guidance to help ensure that your entries stand out from the competition.
Glenmark’s advantage for its UK generic version of AstraZeneca’s Forxiga (dapagliflozin) has quickly been snuffed out, after the originator won on appeal its request for injunctive relief.
With the Global Generics & Biosimilars Awards 2025 taking place in Frankfurt this October, we bring you five key pieces of guidance to help ensure that your entries stand out from the competition.
Denosumab competition is heating up in Europe, with four more companies this month gaining EMA endorsements for their Prolia and Xgeva biosimilar rivals.
