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Sentinel May Expand To Generic Equivalence Studies

 
• By Derrick Gingery

Tool being designed for rapid queries of US Sentinel data to consider generic drug switches, potentially spot equivalence problems.

The US FDA's Sentinel system eventually may grow to help assess generic drug equivalence and improve its ability to find safety problems.

Sentinel has commissioned researchers to develop a tool to characterize product utilization and switching patterns, including between brand drugs and...

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Trump’s FTC Continues The Mission Of Eliminating Orange Book’s Improper Patent Listings

 
• By Urtė Fultinavičiūtė

In a somewhat surprising move, president Donald Trump’s Federal Trade Commission carries the torch in a crusade to delist improper listings from the FDA’s Orange Book. Law firm Polsinelli’s chair Chad Landmon told Generics Bulletin what it means for the generic drug industry.

Biocon To Launch Approved Generic Liraglutide ‘Expeditiously’ In India

 
• By Urtė Fultinavičiūtė

Marking its first vertically integrated GLP-1 product in India, Biocon said the generic liraglutide was approved under CDSCO’s Rule 101, which recognizes approvals from “established and referenced serious regulatory authorities.”

Shilpa Stumbles On Lenvima Challenge And Faces Wait Until 2036

 
• By Dean Rudge

Generic competition to Eisai’s oral-dose blockbuster cancer therapy Lenvima is set to materialize in the US in 2030 – however, for now, that won’t be from ANDA filer Shilpa Medicare.

The Generics Bulletin Podcast: The Global Generics & Biosimilars Awards 2025

 
• By Dave Wallace and Dean Rudge

With entries now open for the Global Generics & Biosimilars Awards 2025 – which takes place in Frankfurt on Wednesday 29 October – Generics Bulletin’s editors discuss all the key details, including tips for entrants, in our latest podcast.

More from Products

Shilpa Stumbles On Lenvima Challenge And Faces Wait Until 2036

 
• By Dean Rudge

Generic competition to Eisai’s oral-dose blockbuster cancer therapy Lenvima is set to materialize in the US in 2030 – however, for now, that won’t be from ANDA filer Shilpa Medicare.

The Generics Bulletin Podcast: The Global Generics & Biosimilars Awards 2025

 
• By Dave Wallace and Dean Rudge

With entries now open for the Global Generics & Biosimilars Awards 2025 – which takes place in Frankfurt on Wednesday 29 October – Generics Bulletin’s editors discuss all the key details, including tips for entrants, in our latest podcast.

Loss Of Exclusivity Product Launches To Fuel Aurobindo’s FY26 Europe Growth

 
• By Vibha Ravi

Aurobindo is banking on launches of loss of exclusivity products and biosimilars to fuel sales in Europe as it awaits a US announcement on tariffs and predicts high single-digit growth overall during FY26 for now