1. Generics Bulletin
  2. >>Business

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

‘America Leans On Hikma’ And Its $1bn Domestic Drug Manufacturing Investment

 
• By Urtė Fultinavičiūtė

Claiming to be a top-three supplier of sterile injectables in the US, Hikma intends to invest $1bn over the next five years to further expand its American manufacturing base, as the threat of tariffs still looms.

US Tariff Overhang Weighs on Chinese API Exports

 
• By Dexter Jie Yan

Chinese API exports to the US fell by 24% year-on-year to $255m in May, when the US and China called a truce in a previously escalating trade war.

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.

More from Business

Advanz Claims Cimzia Biosimilar In Europe Following Alvotech-Xbrane Deal

 
• By Dean Rudge

A proposed biosimilar to one of the lesser spoken about monoclonal antibodies for inflammatory conditions, UCB Pharma’s Cimzia, is the latest candidate to join the significant commercial partnership between Alvotech and Advanz Pharma.

US Tariff Overhang Weighs on Chinese API Exports

 
• By Dexter Jie Yan

Chinese API exports to the US fell by 24% year-on-year to $255m in May, when the US and China called a truce in a previously escalating trade war.

Finding The Right Leadership In A Fast-Moving Industry: Parsity Group’s Nathan Talks Recruitment

 
• By Dave Wallace

What makes the generics and biosimilars sector unique when it comes to executive talent searches and recruitment? Dan Nathan, founder and managing director of Parsity Group, talks to Generics Bulletin about how the firm operates in the fast-moving global off-patent industry.