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European SPC Waiver Becomes A Reality With Council Adoption

 
• By Dave Wallace

Less than a month after it was passed by the European Parliament, a waiver to allow manufacturing of generics and biosimilars during the SPC period, as well as stockpiling for a European ‘day one’ launch upon SPC expiry, has been formally adopted by the European Council.

FinishLine
The long-awaited SPC waiver has passed the finishing line • Source: Shutterstock

A final milestone has been passed by the European Regulation for a waiver that will allow firms to manufacture generics and biosimilars during the term of supplementary protection certificates (SPCs), after it was formally adopted by the European Council.

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US Bill Recap: Senate Judiciary Committee Offers Fresh Start For Reintroduced Off-Patent Drug Bills

 
• By Urtė Fultinavičiūtė

The US Senate Judiciary Committee’s Chairman Chuck Grassley criticized the Senate’s reduced working hours as six previously introduced bills once again land on their desk.

Henlius And Outlook Move Forward With Ophthalmic Bevacizumab

 
• By Dave Wallace

Henlius has reported progress in its development of a bevacizumab product for treating ophthalmic diseases, with its Essex-partnered HLX04-O candidate meeting its primary endpoint in a Phase III trial. Meanwhile, Outlook Therapeutics has taken another shot at getting its own ophthalmic bevacizumab approved in the US after resubmitting its filing.

Pulling Together: Global Regulators Discuss Convergence On Biosimilars

 
• By Dave Wallace

While the biosimilars industry has welcomed individual pockets of progress around regulatory streamlining, it is essential that approaches from global authorities move forward together if they are to have a meaningful impact on biosimilar development. At Medicines for Europe’s annual biosimilars conference, regulators from around the world talked about how their thinking is converging.

Biosimilars Industry Buoyed By EMA Paper On Reducing Clinical Trials

 
• By Dave Wallace

The EMA’s latest move towards a more streamlined process for biosimilar registration in Europe was the hottest topic at last week’s annual biosimilars conference held by Medicines for Europe in Amsterdam. Generics Bulletin discusses the new draft reflection paper and its significance for industry, reports on reactions from the event, and reveals the next steps unveiled by EMA officials.

More from Policy & Regulation

Medicines For Europe Sets Out Vision For Biosimilars Reforms

 
• By Dave Wallace

Four key areas for policy reform were identified by industry association Medicines for Europe at its biosimilars conference in early April, as sector chair Isabell Remus set out the importance of removing barriers to biosimilar competition.

Biosimilars Industry Buoyed By EMA Paper On Reducing Clinical Trials

 
• By Dave Wallace

The EMA’s latest move towards a more streamlined process for biosimilar registration in Europe was the hottest topic at last week’s annual biosimilars conference held by Medicines for Europe in Amsterdam. Generics Bulletin discusses the new draft reflection paper and its significance for industry, reports on reactions from the event, and reveals the next steps unveiled by EMA officials.

Key FDA Officials From Generics And Biosimilars User Fee Programs Laid Off, Said AAM

 
• By Urtė Fultinavičiūtė

Off-patent drug trade groups expressed their concerns that personnel and expertise cuts will affect the agency’s ability to review and approve generics and biosimilars.