Biosimilar User Fee Collections Drop Well Below Estimates, But US FDA Not Worried

The agency hopes application volume increases, but warns the biosimilar user fee revenue will remain volatile.

FDA entrance sign 2016
Estimates for PDUFA and GDUFA were much closer to actual cash collections.

The US Food and Drug Administration's biosimilar user fee program booked a substantial loss in fiscal year 2018 compared to estimates, but the agency is not worried about its ongoing health.

Cash collections were estimated to be $40.2m that year, but the agency only received $29.2m, according to program financial...

Read the full article – start your free trial today!

Join thousands of industry professionals who rely on Pink Sheet 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 Biosimilars

EU Biosimilar Filings, Opinions And Approvals

 

A list of EU biosimilar filings, CHMP opinions and EU marketing authorizations, including details of the biosimilar company, the brand name/INN, indication(s), the reference product/company, and the date and type of event.

Korea’s New Health Minister: ‘Golden Time For The Country To Become A Biopharma Leader’

 
• By 

Multiple Korean ministries, biopharma companies, and other officials convened at a bio innovation roundtable to discuss strategies to emerge as a global biopharma powerhouse.

US FDA Upheaval Forces User Fee Talks To Begin Later Than Usual

 

The fall start of PDUFA and GDUFA negotiations could impact the agreement review process and other parts of the schedule intended to ensure it reaches Congress on time.

Off-Patent Drugs Get UK Spotlight, But Picture Is Still ‘Nuanced’

 

The importance of generic and biosimilar medicines is being recognized by the UK government for the first time. However, Mark Samuels, CEO of Medicines UK, the trade body representing the off-patent industry, says companies are still face multiple hurdles in the market.

More from Biosimilars & Generics

US FDA Gives Leucovorin Unprecedented Path To New Claim Amid ‘Autism Crisis’

 

The Trump Administration's autism campaign convinced GSK to submit an sNDA for its no-longer-marketed leucovorin as a treatment for a rare folate deficiency condition with promises to ensure insurance coverage for autism.

Korea’s New Health Minister: ‘Golden Time For The Country To Become A Biopharma Leader’

 
• By 

Multiple Korean ministries, biopharma companies, and other officials convened at a bio innovation roundtable to discuss strategies to emerge as a global biopharma powerhouse.

Swissmedic Slashes Months Off Review Time For Certain Drug Filings

 

Switzerland’s health care products agency said it had cut the time it takes to review marketing applications for certain drugs submitted via its regulatory reliance procedure because it wants to further enhance the appeal of the pathway.