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FDA-EMA Pilot Could Further Push Global Generic Harmonization, But Will Sponsors Use It?

Industry Offers Varied Responses On US-EU Pilot Program For Complex Generics And Hybrids

 
• By Derrick Gingery

Regulators hope parallel scientific advice pilot for complex generics is more popular than brand program was at start; sponsors want use of foreign comparator products and tighter harmonization.

The FDA-EMA parallel scientific advice pilot for complex generics is an expansion of the existing program for new drugs and biologics • Source: Alamy

Joint development advice from the US Food and Drug Administration and European Medicines Agency on generic drugs has the potential to push both regulators to align their standards, and the potential for faster and cheaper drug approvals globally excites industry.

The grand dream, which could save sponsors millions by preventing duplicative clinical studies and unnecessary testing, likely is a long way off, given the legal and other changes that may...

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More from Regulation

Trump-Trimmed FDA Finally Releases A Batch Of PSGs – Back To Business As Usual?

 
• By Urtė Fultinavičiūtė

After half a year of silence, the US FDA has published 48 product-specific guidances for generic development. With critical staff laid off, will the health agency stick to its updated PSG publishing schedule?

‘The Question Is, What’s Going To Happen Next?’ – The Future For Biosimilars In Europe

 
• By Dave Wallace

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Fresenius Adds To Denosumab Competitors In Europe

 
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Regulatory Recap: ICH To Determine The Future Of Biosimilar Comparative Efficacy Studies

 
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More from Policy & Regulation

US FDA Guidance Roadblock: Writing Continues, But Publication Has Slowed Or Stopped

 
• By Derrick Gingery

Cuts to the FDA’s policy and legal personnel have prevented dozens of product-specific guidances for generic drug development from being published.

‘We Can’t Keep Going On Like This’ – Biosimilars Forum’s Reed Calls For Urgent Changes In US

 
• By Dave Wallace

As the US biosimilars market moves into its second decade, urgent changes are needed at the FDA if biosimilars are to meet their full potential, according to Biosimilars Forum chief executive Julie Reed.

UK-India FTA Could Offer ‘Significant Benefits’ For Generics And Biosimilars

 
• By Dave Wallace

A free trade agreement struck between the UK and India could over “significant benefits for the generic and biosimilar sectors,” Medicines UK believes. The off-patent industry association has also suggested further avenues for collaboration between the two governments on regulatory pathways and supply security.