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GDUFA Research Impacting Generic Development, ANDA Approvals

 
• By Derrick Gingery

Increases in approved ANDAs that were affected by GDUFA research shows the importance of the US FDA’s regulatory science program.

drug discovery research
Bioequivalence method research has helped sponsors obtain ANDA approvals • Source: Shutterstock

US Food and Drug Administration regulatory science research is beginning to pay off in generic drug approvals.

Office of Generic Drugs data shows ANDA approvals directly related to research projects conducted through the generic drug user fee...

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Medicines UK’s Samuels: Off-Patent Drugs Are Finally Gov’s Priority But The Picture Still ‘Nuanced’

 
• By Urtė Fultinavičiūtė

The importance of generic and biosimilar medicines is being recognized by the UK government for the first time. But, as Medicines UK’s CEO Mark Samuels tells Generics Bulletin, companies are still facing multiple hurdles in the market.

BC Partners Bids For Biogaran Buyout – But Will It Face French Pushback?

 
• By Dave Wallace

Private equity firm BC Partners has revealed that it is in exclusive negotiations to acquire Servier’s French generics and biosimilars business Biogaran. But with France’s government having expressed opposition to the sale, could there be strings attached?

Generics Bulletin’s Top 50 Ranking For 2025

 
• By Dave Wallace

This article compiles all of the data from Generics Bulletin’s 2025 ranking of the Top 50 firms across the generics and biosimilars industry, including additional details of how the various financial figures stack up.

The Generics Bulletin Top 50, Part Three: New Firms Enter Global Grouping

 
• By Dave Wallace

In the third instalment of this year’s Generics Bulletin Top 50, we reveal which firms have entered the ranking for the first time.

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Generics Bulletin’s Top 50 Ranking For 2025

 
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This article compiles all of the data from Generics Bulletin’s 2025 ranking of the Top 50 firms across the generics and biosimilars industry, including additional details of how the various financial figures stack up.

The Generics Bulletin Top 50, Part Three: New Firms Enter Global Grouping

 
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Latest EMA Biosimilar Nods Come For Henlius, Alteogen And Biocon

 
• By Dave Wallace

Denosumab, aflibercept and ustekinumab biosimilars received positive opinions from the EMA’s CHMP at its meeting in July, along with an Opsumit generic from Accord.