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Concern Over Biosimilar-To-Biosimilar Switch Could Impact Approval, US FDA Official Says

 
• By Derrick Gingery

OTBB Director Sarah Yim tells the Pink Sheet that FDA cannot make an official determination that biosimilar-to-biosimilar switches are acceptable, but the agency does think about how a product will be used in the market while assessing the application.

biosimilar switching concept
An upcoming FDA workshop could help streamline biosimilar development. • Source: Shutterstock

The US Food and Drug Administration may not be able to mandate that patients can switch between biosimilars, but assessors could nix an application if they believe that could be problematic.

While biosimilars are designed to be used in place of their reference products without concern, the issue of moving patients between biosimilars is becoming increasingly important as some biologics now...

More From The Pink Sheet’s Interview With OTBB Director Sarah Yim

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EU Biosimilar Filings, Opinions And Approvals

 
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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.

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• By Derrick Gingery

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• By Dean Rudge

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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.