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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...

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Bakers And Fishermen: How Biosimilars Manufacturers Are Bridging The Skills Gap

 
• By Dave Wallace

At Medicines for Europe’s annual conference in Brussels, executives from Polpharma Biologics and Gedeon Richter spoke about the challenges in finding biosimilars manufacturing staff with the right backgrounds – and how they are looking to other industries to bridge the skills gap.

Snapshot Of India’s Pharma Manufacturing Network Amid ‘Trumponomics’

 
• By Anju Ghangurde

Collating data on the global manufacturing network of leading Indian drug makers, the markets serviced and production hubs for active pharmaceutical ingredients. Will ongoing geopolitical tensions and policy shifts have a bearing on some of these down the line?

European Industry Calls For Support As It Juggles Multiple Challenges

 
• By Dave Wallace

At Medicines for Europe’s legal and annual conferences in Brussels last week, multiple key issues competed for attention, giving the generics and biosimilars industry plenty to think about at a critical time for EU pharma reform.

Sandoz Starts Construction On $440m Slovenian Biosimilars Plant

 
• By Dave Wallace

Sandoz has begun constructing a major biosimilars manufacturing facility in Slovenia that is set to become operational in 2028. A $440m investment in the project adds to local biosimilars initiatives that together total over $1bn, helping Sandoz to move out of the shadow of former parent Novartis.

More from Business

Who’s Hired? Stada Picks Biogen’s Biosimilars Chief Henshaw To Lead Specialty Segment

 
• By Dave Wallace

Stada has appointed former Biogen biosimilars head Ian Henshaw as the new leader of its Specialty segment. Meanwhile, Craig Burton has left the AAM for Fresenius Kabi, Australia's GBMA is looking for a new chief executive, and Speranza, Outlook and EuroAPI have announced new appointments.

Three’s A Crowd? Celltrion Launches Denosumab In US

 
• By Dave Wallace

A third pair of Prolia and Xgeva rivals has now been launched in the US, with Celltrion throwing its hat into the ring after denosumab launches by Sandoz and Fresenius Kabi. But this is only the beginning for what is shaping up to be another highly competitive biosimilars market.

Snapshot Of India’s Pharma Manufacturing Network Amid ‘Trumponomics’

 
• By Anju Ghangurde

Collating data on the global manufacturing network of leading Indian drug makers, the markets serviced and production hubs for active pharmaceutical ingredients. Will ongoing geopolitical tensions and policy shifts have a bearing on some of these down the line?