Amgen has filed a Biologics License Application (BLA) with the United States (U.S.) Food and Drug Administration (FDA) for ABP 501, a biosimilar candidate to Humira (adalimumab).
Amgen said Wednesday it believed that the submission was the first adalimumab biosimilar application submitted to the FDA.
The company said it represented its first BLA submission using the 351(k) biosimilar pathway.
“The submission of Amgen’s first biosimilar application to the FDA is an exciting milestone, expanding our inflammation portfolio to provide additional therapeutic options to patients,” said Sean E. Harper, M.D., executive vice president of Research and Development at Amgen.
“Patients with chronic inflammatory conditions are faced with a significant burden of disease requiring long-term treatment. Amgen’s branded biologic medicines and biosimilars are developed and manufactured according to the same high standards, and we are committed to delivering high-quality medicines to patients with serious inflammatory diseases.”
ABP 501 is a biosimilar candidate to adalimumab, an anti-TNF-α monoclonal antibody, which is approved in many countries for the treatment of various inflammatory diseases.