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Biosimilar Post-Approval Change Guidance Coming From US FDA

 
• By Derrick Gingery

Guidance, which is undergoing clearance, will address other products as well and might be released by the end of the year.

Binoculars hang on a wooden fence background
Biosimilar sponsors' postmarket responsibilities may be coming into more focus.

The US FDA intends to give biosimilar sponsors more information about its expectations for post-approval changes soon, but not in a stand-alone guidance document.

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