Amgen (AMGN) has submitted its Biologics License Application with the FDA for ABP 501, a biosimilar candidate to AbbVie’s (ABBV) Humira. The filing represents Amgen’s first BLA submission using the 351(k) biosimilar pathway.
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Amgen (AMGN) has submitted its Biologics License Application with the FDA for ABP 501, a biosimilar candidate to AbbVie’s (ABBV) Humira. The filing represents Amgen’s first BLA submission using the 351(k) biosimilar pathway.