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FDA Releases Biosimilar User Fee Act Rates for Fiscal Year 2023

Last week, the FDA announced the Biosimilar User Fee Act (BsUFA) rates for the 2023 fiscal year, which runs from October 1, 2022 through September 30, 2023. The FDA determined these rates pursuant to the Food and Drug...more

Coherus Announces FDA Approval of CIMERLI (ranibizumab-eqrn)

​​​​​​​On August 2, 2022,  Coherus BioSciences, Inc. announced that the FDA approved CIMERLI™ (ranibizumab-eqrn) as a biosimilar interchangeable with LUCENTIS® (ranibizumab injection) for all five indications, with 12 months...more

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