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

The Same But Different: Biden Budget Proposes Flexibility For Generic Drug-Device Combos, ‘Skinny Labels’

 
• By Sarah Karlin-Smith

President Biden's fiscal year 2024 budget pushes new legislative changes to get generic drugs to market faster.

inhalers
FDA wants authority to approve generic drug-device combo products that have “certain differences” from the brand • Source: Shutterstock

The US Food and Drug Administration is seeking legislative changes that would permit it to approve generic drug-device combination products with “certain differences” in the device component compared to the brand.

The push is one of a handful of legislative asks intended to enhance generic competition included in the Biden administration’s fiscal year 2024 budget request.

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

ANI Raises Generics Guidance As Exclusive Prucalopride Drives Growth

 
• By Dean Rudge

ANI Pharmaceuticals says it has delivered an “exceptionally strong first quarter,” with total sales reaching over $197m, amid plans to kick off a Phase IV clinical trial for Cortrophin Gel for acute gouty arthritis later this year.

Aurobindo, MSN Fall To US Nuplazid Patent Expiring In August 2038

 
• By Dean Rudge

Acadia’s Nuplazid for hallucinations and delusions associated with Parkinson’s disease psychosis is looking safe from generic competition – for now – until well into the next decade, following a favorable infringement and validity decision by a US district court.

Hikma Eyes $5bn Sales Target As It Sets Out Plans To 2030

 
• By Dave Wallace

Unveiling a new name for its generics business, Hikma has at the same time set out medium-term financial goals for its business that include three-year growth objectives for its sales and profits, as well as aiming at a $5bn turnover target by 2030.

Cipla Leadership’s Early Take On Trump’s Pricing EO And Pipeline Progress

 
• By Anju Ghangurde

Cipla's CEO underlines that US generic prices are already “very significantly comparable” with the rest of the world and expects President Donald Trump's executive order on drug pricing to primarily impact branded pharmaceuticals. The company also shared updates on its US pipeline.

More from Products

Aurobindo, MSN Fall To US Nuplazid Patent Expiring In August 2038

 
• By Dean Rudge

Acadia’s Nuplazid for hallucinations and delusions associated with Parkinson’s disease psychosis is looking safe from generic competition – for now – until well into the next decade, following a favorable infringement and validity decision by a US district court.

Aurobindo Racks Up Another Biosimilar Nod With Filgrastim In UK

 
• By Dave Wallace

Aurobindo’s run of biosimilar registration successes continues, with the firm’s CuraTeQ subsidiary picking up approval for its Zefylti version of filgrastim in the UK.

J&J Hits Back Over Private-Label Stelara Biosimilar In US

 
• By Dave Wallace

After being refused an injunction as part of ongoing litigation over a private-label ustekinumab biosimilar being marketed in the US by Sandoz and Samsung Bioepis, Stelara originator Johnson & Johnson is continuing to pursue an appeal. However, newly-unsealed court documents suggest the brand company had demonstrated a likelihood of success - and reveal further details about the case, including the identity of the PBM involved and why the injunction request was denied.