THOUSAND OAKS (dpa-AFX) - Amgen (AMGN) announced the U.S. FDA has accepted for review the company's Biologics License Application for ABP 501, a biosimilar candidate to Humira (adalimumab). The FDA has set a Biosimilar User Fee Act target action date of Sept. 25, 2016.
ABP 501 is a biosimilar candidate to adalimumab, an anti-TNF-? monoclonal antibody, which is approved in many regions for the treatment of several inflammatory diseases.
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