Friday April 19, 2024 | Last Update: April 19, 2024 EDT
Amgen Inc. has announced in a press release the submission of a Biologics License Application to the U.S. Food and Drug Administration (FDA) for ABP 501, a biosimilar candidate to Humira, or adalimumab, an anti-TNF-α monoclonal antibody. The application is Amgen’s first Biologics License Application submitted using the 351 (k) biosimilar pathway.
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