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Home » Time for US biosimilar path to catch up with the science?
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Time for US biosimilar path to catch up with the science?

Sep. 6, 2023
By Mari Serebrov
Now that the U.S. FDA has nearly 15 years of experience with developing and implementing a biosimilar pathway, it’s time for that regulatory path to catch up with the science, according to experts that have been involved in biosimilar development even before Congress passed the Biologics Price Competition and Innovation Act that created the framework for the U.S. biosimilar market.
BioWorld Regulatory Biosimilar U.S. EMA FDA

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