Biosimilar sponsors may find the Creating and Restoring Equal Access to Equivalent Samples (CREATES) Act, intended to ensure their access to reference product for testing, is not as clear as with conventional generics and that more litigation may be needed to address some issues.
Is CREATES Act Equipped To Handle Biosimilar Complaints?
Biosimilar sponsors need multiple reference product lots and expiration dates, and questions remain about whether they can obtain enough to fulfill all regulatory requirements under a CREATES Act mandate, Teva attorney says.
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