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BioWorld - Sunday, December 29, 2024
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» Inspections, IRs fly in the ointment of US biosimilar program
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Inspections, IRs fly in the ointment of US biosimilar program
March 22, 2022
By
Mari Serebrov
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The U.S. biosimilar review process seems to be hitting its stride, with the FDA approving, in the first cycle, 67%, or 14, of the 21 biosimilar applications filed and acted upon in the first four years of BsUFA II.
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