1. Pink Sheet

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

 
• By Dave Wallace

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...

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