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Biosimilar Guidances: Broader Populations Permitted; More Immunogenicity Requested

 
• By Brenda Sandburg

New draft Q&A and three final guidances from FDA offer pros and cons for sponsors of biosimilar applications.

FDA has tweaked its biosimilars guidances to give sponsors more information about how to bridge data, extrapolate from one condition, choose a study population, and conduct immunogenicity testing.

At the end of April, the agency issued three final guidances with modifications to draft documents published in 2012 Also...

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More from United States

Initial Medicare Price Offer For Ozempic, Wegovy Almost Half Off Net, Analysis Suggests

 
• By Cathy Kelly

Only Bausch Health’s Xifaxan may have had a lower initial offer among the 15 drugs in the current Medicare price negotiation round, researchers at the University of Washington and the University of California, San Diego, projected.

Industry Rethinking Visual Elements And Quality-Of-Life Claims After US FDA Drug Ad Crackdown

 
• By Sue Sutter

Sponsors should consider whether their TV commercials contain the same number of scene changes during the major statement as ads that received a violation letter.

Gene Therapy Sponsors Seek More US FDA ‘Platform’ Guidance, Offer Master File Idea

 
• By Michael McCaughan

One clear message from a US FDA listening session on leveraging knowledge across cell and gene therapy products is sponsors want more guidance on how the FDA’s new platform therapy pathway will function.

Will US FDA’s Missed Hiring Goals Impact Upcoming User Fee Negotiations?

 
• By Derrick Gingery

The FDA only added 39% of the promised new user fee-related hires in FY 2025 and also missed hiring goals for the previous two fiscal years.

More from North America

Will US FDA’s Missed Hiring Goals Impact Upcoming User Fee Negotiations?

 
• By Derrick Gingery

The FDA only added 39% of the promised new user fee-related hires in FY 2025 and also missed hiring goals for the previous two fiscal years.

Legal ‘Squishiness,’ DoJ Reorganization Could Shape Ad/Promo Enforcement Strategy

 
• By Sue Sutter

The extent of FDA and Justice Department coordination on recent warning and untitled letters is unclear, but the “squishy” issues cited in many of the letters and recent elimination of DoJ’s Consumer Protection Branch could influence legal action, industry lawyers said.

First Cohort Shows Many Routes To US FDA’s Commissioner’s National Priority Voucher

 
• By Sarah Karlin-Smith

Experts raised concerns about the pilot program's larger than expected size and the lack of transparency about the reasons the cohort deserved vouchers over a pool that the FDA said included hundreds of candidates.