What’s Next? Five Things To Look Out For In January

Alvotech Waits On Pivotal FDA Inspection; JP Morgan Conference Hits San Francisco

Generics Bulletin previews the most noteworthy and anticipated events for January 2024.

What's Next Image

Alvotech is set to face a long-awaited US Food and Drug Administration reinspection of its Reykjavik facility in January, in a key milestone for the Icelandic firm that could pave the way finally to a US approval for its Teva-partnered AVT02 adalimumab high-concentration interchangeable biosimilar to Humira.

The FDA’s reinspection at Reykjavik has been scheduled for 10-19 January. Complete response letters issued by the agency for Alvotech’s...

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 Manufacturing

Kirsty Gives Biocon A First Interchangeable US Insulin Aspart Biosimilar

 
• By 

After years of waiting, Biocon Biologics has finally snagged US FDA approval for its insulin aspart biosimilar – along with a first designation of interchangeability. However, Sanofi’s Merilog version is already approved as a rival to Novo Nordisk’s Novolog.

Room For Improvement? EU Industry Prepares Feedback For SPC Manufacturing Waiver Review

 
• By 

As the European Commission prepares a formal evaluation of the SPC manufacturing waiver, the generics and biosimilars industry is getting ready to provide detailed feedback on what works – and what doesn’t. At Medicines for Europe’s legal affairs conference, delegates heard the latest updates.

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

 
• By 

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’

 

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?

More from Business

Room For Improvement? EU Industry Prepares Feedback For SPC Manufacturing Waiver Review

 
• By 

As the European Commission prepares a formal evaluation of the SPC manufacturing waiver, the generics and biosimilars industry is getting ready to provide detailed feedback on what works – and what doesn’t. At Medicines for Europe’s legal affairs conference, delegates heard the latest updates.

Wockhardt Pivots To Biosimilar Insulins Focus As It Confirms US Generics Exit

 
• By 

Wockhardt is exiting the US generics market through voluntary liquidation of its loss-making US subsidiaries to double down on innovation and focus on antibiotics and biosimilar insulins.

Biocon’s Denosumab Biosimilar Approved In The UK As Competition Grows In Europe

 

Denosumab biosimilar ranks are filling up in Europe as approvals flood in. Yet, little is known about the launch dates.