US FDA’s Yim Hints At Revisiting Biosimilar Suffix Naming Convention, Reassures On Immunogenicity

In an ‘ask me anything’ Q&A on Reddit, Sarah Yim, director of US FDA’s Office of Therapeutic Biologics and Biosimilars, offered some insights on the US biologics naming convention, biosimilar interchangeability, and the possibility of future competition on cell and gene therapies.

Reddit Ask Me Anything
Sarah Yim challenged Reddit users to "ask me anything" about biosimilars. • Source: Shutterstock

Sarah Yim, director of the US Food and Drug Administration's Office of Therapeutic Biologics and Biosimilars, suggested the long-bemoaned suffix in biosimilar generic names could be reconsidered during a Reddit "ask me anything" session.

Key Takeaways

  • The OTBB Director said the pros and cons of the suffix in the biosimilar naming convention will continue to be assessed.

Appearing in the “medicine” subreddit, described as “a virtual lounge for physicians and other medical professionals from around the world...

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".

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

 

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

 

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 

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

 

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 

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 

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.