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

Will Continuous Manufacturing Mean Continuous Generic Delay? FDA Hears AAM's Warning

 
• By Bowman Cox

Association for Accessible Medicines calls for US FDA to guard against use of continuous manufacturing methods to protect brand drugs from batch-manufactured generic drugs that may be of lower but still acceptable quality. Then FDA approves first generic of a continuously manufactured drug.

Batch versus continuous manufacturing
The future may be continuous -- and then back to batch

The organization that represents generic drug companies in the US has taken a hard line against technological innovation in pharmaceutical manufacturing that unfairly increases the quality of brand drugs.

The Association for Accessible Medicines Nov. 17 warned FDA to "remain vigilant" against brand firms' use of new technologies like...

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

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

China’s Qilu Looks To US Hospitals Market With Sagent Injectables Collaboration

 
• By Dean Rudge

Sagent and Qilu will look to enhance access, reduce treatment costs, and strengthen supply chains after striking an alliance for a portfolio of the Chinese firm’s complex injectables.

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.