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Biosimilar Guidances Expected In ‘Near Future,’ But Unnecessary, FDA Says

 
• By Nielsen Hobbs

Naming and labeling questions will likely be resolved with agency actions on pending biosimilar applications.

FDA is planning to issue several additional guidances on biosimilars in the “near future,” Sally Howard, Deputy Commissioner for Policy, Planning, Legislation And Analysis, said. But that policy work is not impacting the agency’s review of pending applications.

In fact, the user fee deadlines for the two biosimilar applications have been publically announced seem to be driving the...

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