Biosimilar Interchangeability Designation Would Be Nixed Under Biden Proposal

 
• By Derrick Gingery
  
Generate a summary of this article
Listen to this article
Beta

The proposal is not expected to cost or save the government money, but is expected to increase biosimilar uptake, according to budget documents.

budget
The FDA would receive about $7.2bn in budget authority and user fees in Biden's FY 2025 budget request. • Source: Shutterstock

President Biden proposed eliminating the biosimilar interchangeability designation in his fiscal year 2025 budget request, likely a reflection of the push to lower drug prices and the evolving scientific thinking about the products.

Key Takeaways

  • Eliminating the interchangeability distinction would bring the US in line with other major regulators and reflects the current science, Biden administration officials said.

Current law states that an approved biosimilar must receive an interchangeability designation before it can be substituted for its reference...

Pink Sheet Podcast

Learn what's happening at the US FDA. On the go.

Derrick Gingery and the team bring you a weekly "Drug Fix".

SpotifyApple PodcastsWebsite

More from Biosimilars

GB-Free-Tracker-The Secret to Walking More: It’s Not Counting Steps

We’ve all been told that walking 10,000 steps a day is the magic number for better health. But what if the real secret to walking more isn’t about counting steps at all? In this article, we explore how focusing on motivation, environment, and mindset can help you build a walking habit that lasts.

Regeneron’s Linvoseltamab CRL Underlines Risks Of Third-Party Manufacturers

 
• By Bridget Silverman

The bispecific antibody is the latest example of a growing number of biologics receiving complete response letters related to third-party manufacturing facilities.

Facility Deficiencies Drive Rising CRL Rates For CDER Biologics

 
• By Bridget Silverman

A US FDA analysis found that facility inspection issues were the fastest growing factor in the recent rise of complete response letters for biologics licensing applications, in part reflecting the limitations of single-product inspections at contract facilities manufacturing multiple products.

EU Biosimilar Filings, Opinions And Approvals

 
• By Ian Schofield

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.

More from Biosimilars & Generics

Facility Deficiencies Drive Rising CRL Rates For CDER Biologics

 
• By Bridget Silverman

A US FDA analysis found that facility inspection issues were the fastest growing factor in the recent rise of complete response letters for biologics licensing applications, in part reflecting the limitations of single-product inspections at contract facilities manufacturing multiple products.

Novartis Takes Fight To The FDA After US Entresto Generic Approval

 
• By Dean Rudge

Novartis continues to fight tooth and nail to protect its $3bn Entresto brand in the US following the latest FDA approval of a generic version.

EU Biosimilar Filings, Opinions And Approvals

 
• By Ian Schofield

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.