SPC waiver may be altered on stockpiling and disclosure

European generics and biosimilars manufacturers should be allowed to stockpile within the European Union (EU) for day-one launch ahead of supplementary protection certificate (SPC) expiry, under proposed amendments to a draft SPC manufacturing waiver. Moreover, according to the amendments put forward in an opinion by a rapporteur for the European Parliament’s committee on environment, public health and food safety (ENVI), limits will also be put on the extent to which commercially-sensitive manufacturing information provided by the generics industry must be published and shared by national authorities.

European generics and biosimilars manufacturers should be allowed to stockpile within the European Union (EU) for day-one launch ahead of supplementary protection certificate (SPC) expiry, under proposed amendments to a draft SPC manufacturing waiver. Moreover, according to the amendments put forward in an opinion by a rapporteur for the European Parliament’s committee on environment, public health and food safety (ENVI), limits will also be put on the extent to which commercially-sensitive manufacturing information provided by the generics industry must be published and shared by national authorities.

The draft opinion eases industry concerns over the SPC waiver, which has been an industry goal for years but which...

Read the full article – start your free trial today!

Join thousands of industry professionals who rely on Generics Bulletin for daily insights

  • Start your 7-day free trial
  • Explore trusted news, analysis, and insights
  • Access comprehensive global coverage
  • Enjoy instant access – no credit card required

More from Policy & Regulation

Bio-Thera Matches Alvotech With US Golimumab Filing Acceptance

 
• By 

Bio-Thera is one step closer to launching a biosimilar to Johnson & Johnson’s Simponi in the US, following FDA acceptance of its BAT2506 proposed golimumab candidate.

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

 
• By 

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 

Teva seeks a dedicated development program and first-cycle approval metrics for complex generics. Role of artificial intelligence in the generic drug review process is a talking point for both agency and industry at reauthorization kickoff meeting.

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

 

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.

More from Generics Bulletin

ViiV Extends Voluntary License For Long-Acting Cabotegravir As HIV Treatment

 

The Medicines Patent Pool’s extended voluntary license to produce long-acting cabotegravir to treat HIV is a win for patients living in LMICs, as the WHO updated its guidance to recommend it as an alternative treatment option.

Krka Passes €1bn Threshold In Just Six Months

 
• By 

Krka has reported its strongest-ever half-year results, surpassing €1bn in sales and growing EBITDA by 8%. Solid performance across most regions, particularly Eastern and Central Europe, supported stable margins and a positive full-year outlook.

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

 
• By 

Teva seeks a dedicated development program and first-cycle approval metrics for complex generics. Role of artificial intelligence in the generic drug review process is a talking point for both agency and industry at reauthorization kickoff meeting.