1. Pink Sheet
  2. >>Biosimilars & Generics
  3. >>Biosimilars

From Interchangeability To Invisibility: FDA Wipes Designation From Biosimilar Labels

New Draft Guidance Urges Removal Of Interchangeability Designation From Biosimilar Labeling

 
• By Dave Wallace

Amid continuing stakeholder confusion over the meaning and significance of the US FDA’s interchangeability designation for biosimilars, the agency has now recommended omitting altogether details of interchangeability from biosimilar labels.

Three vials with blank white labels, syringe in background
FDA: biosimilar labels should not include interchangeability details • Source: Shutterstock

Ever since its introduction, the US Food and Drug Administration’s interchangeability designation for biosimilars has been a much-debated topic among industry stakeholders. But now, the latest FDA draft guidance has recommended removing the designation from biosimilar labels altogether.

Key Takeaways:

  • New US FDA draft guidance has recommended removing details of interchangeability from biosimilar labels

Citing the difficultly of appropriately labeling interchangeable biosimilars and updating labeling “without causing undue confusion” – as well as suggesting...

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
Start Free Trial

Already a subscriber?

More from Biosimilars

ICH Targets RWE, Rare Diseases, Biosimilars, ATMPs In New Guideline Push

 
• By Vibha Sharma

The International Council for Harmonisation has identified four new topics that can benefit from global regulatory alignment, with timelines for initiating work to be determined later.

EU Biosimilar Filings, Opinions And Approvals

 
• By Neena Brizmohun

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.

Pulling Together: Global Regulators Discuss Convergence On Biosimilars

 
• By Dave Wallace

While the biosimilars industry has welcomed individual pockets of progress around regulatory streamlining, it is essential that approaches from global authorities move forward together if they are to have a meaningful impact on biosimilar development. At Medicines for Europe’s annual biosimilars conference, regulators from around the world talked about how their thinking is converging.

Missing BsUFA Revenue Trigger Could Open US FDA Staff To Criminal Penalty

 
• By Derrick Gingery

Massive layoffs and the biosimilar user fee program’s historic flirtation with the non-user fee spending requirements raise concerns that the FDA could lose its ability to collect BsUFA revenue, which could mean a fine or jail time for agency staff.

More from Biosimilars & Generics

Pharma Industry Argues Tax, Other Incentives Better Than Tariffs

 
• By Jessica Merrill

Pharmaceutical industry organizations offered alternatives to tariffs that could maintain a secure domestic supply chain in public comments filed in response to a federal 232 investigation.

US FDA Guidance Roadblock: Writing Continues, But Publication Has Slowed Or Stopped

 
• By Derrick Gingery

Cuts to the FDA’s policy and legal personnel have prevented dozens of product-specific guidances for generic drug development from being published.

Viatris Agrees To $335m Opioid Settlement Ending US State, Local Government Cases

 
• By Dean Rudge

Viatris joined Hikma and Amneal, in signing agreements for cash settlements that resolve allegations its practices fueled the US’ deadly opioid epidemic.