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Concerns Over PREVAIL Act Persist, Even With Amendment To Shield Off-Patent Drugs

The Bill Received A Close Vote Of 11-10 By The Senate Judiciary Committee

 
• By Urtė Fultinavičiūtė

Despite the US legislation gaining support from Democratic candidates, who have fought against anticompetitive pharma behavior, many have shared concerns that the amended PREVAIL Act will still negatively impact generic drugs.

US Senator Chris Coons
Chris Coons is one of the PREVAIL Act's lead sponsors (Shutterstock)

The controversial Promoting and Respecting Economically Vital American Innovation Leadership Act was finally voted by the Senate Judiciary Committee after the markup was postponed multiple times since the summer.

Also known as the PREVAIL Act (S.2220), the bill narrowly moved forward to the Senate...

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‘Our Position Has Naturally Shifted’ – How Standalone Sandoz Is Taking On Originator Abuses

 
• By Dave Wallace

As a standalone generics and biosimilars company, Sandoz now feels freer to speak out against originator abuses of intellectual property, the firm’s global IP head Julia Pike tells Generics Bulletin, including challenges to Bayer on rivaroxaban and Amgen on etanercept.

ANDA User Fees: Complex Generics, Transparency, Communications Are Early Negotiation Targets

 
• By Sue Sutter

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Making The UK A Leading Biosimilar Launch Destination – Realistic Or Optimistic?

 
• By Urtė Fultinavičiūtė

Experts discussed the UK government’s commitment to make the country a desirable destination for companies to launch their biosimilars at a recent conference hosted by Medicines UK.

Room For Improvement? EU Industry Prepares Feedback For SPC Manufacturing Waiver Review

 
• By Dave Wallace

As the European Commission prepares a formal evaluation of the SPC manufacturing waiver, the generics and biosimilars industry is getting ready to provide detailed feedback on what works – and what doesn’t. At Medicines for Europe’s legal affairs conference, delegates heard the latest updates.

More from Generics Bulletin

Kirsty Gives Biocon A First Interchangeable US Insulin Aspart Biosimilar

 
• By Dave Wallace

After years of waiting, Biocon Biologics has finally snagged US FDA approval for its insulin aspart biosimilar – along with a first designation of interchangeability. However, Sanofi’s Merilog version is already approved as a rival to Novo Nordisk’s Novolog.

MSN’s Entresto Generic Temporarily Blocked As Key US Patent Expires

 
• By Dean Rudge

The Federal Circuit has temporarily blocked MSN from launching a generic version of Entresto, granting Novartis short-term relief while it reviews the company’s emergency Rule 8 motion for a longer injunction.

Making The UK A Leading Biosimilar Launch Destination – Realistic Or Optimistic?

 
• By Urtė Fultinavičiūtė

Experts discussed the UK government’s commitment to make the country a desirable destination for companies to launch their biosimilars at a recent conference hosted by Medicines UK.