1. Generics Bulletin
  2. >>Business
  3. >>Manufacturing

Two-Year Stockpiling Provision ‘Vastly Improves’ European SPC Waiver

 
• By Dave Wallace

The latest vote from the European Parliament’s legal committee has been praised by industry for allowing firms to stockpile for two years ahead of SPC expiry to prepare for a ‘day one’ launch.

EUParliament
The European Parliament's Legal Committee Has Passed A New Agreement • Source: Shutterstock

A planned waiver to allow generics and biosimilars firms to manufacture in the European Union (EU) during the term of supplementary protection certificates (SPCs) will include the possibility of stockpiling for ‘day one’ launch within the EU as well as manufacturing for export, according to a compromise agreement approved by the European Parliament’s legal committee, JURI.

European off-patent industry Medicines for Europe has warmly welcomed the move, which comes shortly after the European Council approved a...

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
Start Free Trial

Already a subscriber?

More from Manufacturing

Reshaped Xbrane Allies With OneSource For Commercial Biosimilar Manufacturing

 
• By Dean Rudge

Xbrane Biopharma is partnering with India’s OneSource Specialty Pharma to manufacture its biosimilars, including its much-delayed ranibizumab product Ximluci. The move follows a SEK240m funding round and strategic refocus on commercialization after divesting key R&D assets to Alvotech.

Xbrane Sets Date For Latest Run At Ranibizumab In US

 
• By Dave Wallace

After a series of setbacks for its Lucentis (ranibizumab) biosimilar filing in the US, Xbrane Biopharma now has a fresh action date from the FDA – although any approval will be contingent on a successful agency reinspection of its manufacturing sites.

Zydus Strikes Landmark $141m Agreement To Break Into Global CDMO Business

 
• By Dean Rudge

Zydus Lifesciences said it would be able to leverage supply chain dynamics and a “favorable geopolitical environment” to expand its reach in the US and globally as it penned a trio of agreements to plant its flag in the global CDMO space.

Glenmark Adamant FDA Monroe Site Reinspection Could Happen ‘Any Time’

 
• By Dean Rudge

A weak second half in Glenmark’s India business during the firm’s 2025 financial year took the gloss off its earnings somewhat for the year. However, Glenmark is plotting several avenues to return to growth, in both of its core business regions: India and the US.

More from Business

Tevogen Will House Generics Unit In Much-Expanded New Headquarters

 
• By Dean Rudge

Tevogen is looking to accelerate its growth with a major expansion of its headquarters in Warren, New Jersey, more than doubling its footprint to centralize research and development, regulatory, and corporate functions. The new facility will support the company’s evolving initiatives.

Endo Offloads Paladin As Shareholders Approve Mallinckrodt Merger

 
• By Dave Wallace

As it prepares to complete its $6.7bn merger with Mallinckrodt, Endo has divested its International Pharmaceuticals business – consisting primarily of Canadian specialty firm Paladin Pharma – to Knight Therapeutics.

Beyond ‘Vanilla’ Generics: How Lupin Is Evolving To Stay Ahead Of The UK Competition

 
• By Dave Wallace

As UK players face increasing competitive pressures on “vanilla” generics – including potential new market entrants from China – Ben Ellis, Lupin’s UK and Ireland general manager, explains how the company is focusing on more complex opportunities that require a hybrid generic and branded mindset.