1. Generics Bulletin
  2. >>Products
  3. >>Generics

One Year On, FDA Generic Drug Cluster Focuses On Facilitating Collaboration

Group Has Made Significant Progress Regarding Data Sharing

 
• By Chloe Kent

Following its inaugural year, the FDA’s Generic Drug Cluster has formed data sharing arrangements concerning a number of vital indications.

Wooden figures of people gathered around green globe
Several initiatives in the off-patent industry are now focused on regulatory harmonization • Source: Shutterstock

The US Food and Drug Administration’s Generic Drug Cluster has facilitated the gathering and combining of data in several key indications during its first year in operation, a progress report has revealed.

The group said the discussions it has had over the last year “promoted an understanding of approval basis focusing on...

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 Generics

Danish Probe Could Influence Rethink Of Controversial EU Urban Wastewater Rules

 
• By Francesca Bruce

Some medicines may be subject to price rises that make them unaffordable if the burden of paying for extra wastewater treatment is not more fairly distributed across different industries, the Danish pharmaceutical industry association has warned.

Zydus Looks To Ride gIbrance Exclusivity Wave; GLP-1 Battle-Ready With Differentiated Pen

 
• By Vibha Ravi

Ibrance is losing share to other drugs, but Zydus looks forward to a late 2027/early 2028 launch of its generic in the US where partner Synthon might have 180-day exclusivity. In India, as Lilly launches Mounjaro KwikPen, it hopes for a GLP-1 edge with a differentiated device and formulation.

UPC Imposes Wide Cross-Border Injunction On Zentiva In Ofev Patent Clash

 
• By Dean Rudge

The UPC Court of Appeal has signaled that in pharma disputes, being ready to launch can be as risky as actually launching. In a major setback for Zentiva, the court ruled that completing certain steps well before patent expiry amounted to “setting the stage” for infringement.

Hikma Rides Price Gap as Novo’s Ozempic, Wegovy Costs Climb

 
• By Dean Rudge

Hikma is seeing increased US demand for its generic Victoza (liraglutide) after the end of semaglutide compounding lifted prices for Novo Nordisk’s Ozempic and Wegovy. Meanwhile, the company is not for now pursuing semaglutide generics in the US or EU due to patent protection, but is targeting MENA.

More from Products

Zydus Looks To Ride gIbrance Exclusivity Wave; GLP-1 Battle-Ready With Differentiated Pen

 
• By Vibha Ravi

Ibrance is losing share to other drugs, but Zydus looks forward to a late 2027/early 2028 launch of its generic in the US where partner Synthon might have 180-day exclusivity. In India, as Lilly launches Mounjaro KwikPen, it hopes for a GLP-1 edge with a differentiated device and formulation.

Formycon’s Search For Keytruda Biosimilar Partner Is Key To Deliver FY2025 Guidance

 
• By Urtė Fultinavičiūtė

With H1 revenues not even hitting double-digits, Formycon is bidding on partnerships and royalties to generate at least €46m over the next half-year to reach its revenue goal.

$160m War Chest Readied For Aquestive’s Oral Epinephrine Film Launch

 
• By Dean Rudge

Filed through the FDA’s 505(b)(2) hybrid new drug application pathway, Aquestive Therapeutics’ proposed Anaphylm (epinephrine) sublingual film has received major financial backing with a pair of funding deals.