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Amgen submits application to FDA for adalimumab biosimilar

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Amgen recently announced it has submitted a Biologics License Application with the FDA for a biosimilar candidate to Humira.

The biosimilar, known as ABP 501, is believed by the company to be the first of its kind for Humira (adalimumab, AbbVie) submitted to the FDA. According to a company release, the submission includes analytical, clinical and pharmacokinetic data, as well as data to aid patients in the transition from adalimumab to ABP 501.

“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,” Sean E. Harper, MD, executive vice president of Research and Development at Amgen, said in the release. “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.”

Reference:

www.amgenbiosimilars.com