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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...

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Sandoz Streamlines More Trials As First-Half Biosimilars Sales Hit $1.5bn

 
• By Dave Wallace

Sandoz has revealed plans to streamline more biosimilar trials amid evolving regulatory moves towards minimizing the need for comparative efficacy studies. The disclosure was just one of many pipeline and portfolio updates provided as the firm delivered positive first-half results.

Aurobindo Expects Lannett Acquisition To Pass FTC Scrutiny; Q1 US Revenue Falls

 
• By Vibha Ravi

Aurobindo is confident its planned Lannett acquisition will pass US FTC scrutiny after an attempt to acquire Sandoz assets was called off in 2020 post a delay in approval. The deal could widen Aurobindo’s US manufacturing presence at a time when its US Q1 revenue saw a year-on-year decline.

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.

Regulatory Recap: FDA Starts ‘Radical Transparency’ Era After Publishing Over 200 CRLs

 
• By Urtė Fultinavičiūtė

Generics Bulletin reviews global regulatory developments across the world.

More from Policy & Regulation

‘Europe Has To Make Up Its Mind’ – Medicines For Europe’s Sieger On The Path Ahead

 
• By Dave Wallace

At an eventful time for the European generics and biosimilars industry, Medicines for Europe interim president and Polpharma CEO Markus Sieger talks about what the European healthcare sector needs and what the off-patent sector can deliver.

FDA Inspection Finds Leaks and Mold at Sun Pharma Halol Facility

 
• By Dean Rudge

Sun Pharma is facing renewed scrutiny after a scathing US Food and Drug Administration inspection at its Halol facility in Gujarat painted a grim picture of a facility operating in disregard of basic pharmaceutical safety standards.

Regulatory Recap: FDA Starts ‘Radical Transparency’ Era After Publishing Over 200 CRLs

 
• By Urtė Fultinavičiūtė

Generics Bulletin reviews global regulatory developments across the world.