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US FDA Ends Nearly 2-Year Drought In Biosimilar Action Package Postings

Executive Summary

Posting of final review documents for three biosimilars – Cyltezo, Mvasi and Fulphila – brings to seven the number of licensed biosimilars for which action packages with underlying analytical and clinical data are publicly available. FDA has attributed posting delays to a backlog in the redaction queue but is not prioritizing postings based upon order of approval or commercial availability.


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