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.
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
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