Amgen Submits Application to FDA for Humira Biosimilar


Submission bolstered by trials evaluating biosimilar candidate in moderate-to-severe plaque psoriasis and rheumatoid arthritis.

Submission bolstered by trials evaluating biosimilar candidate in moderate-to-severe plaque psoriasis and rheumatoid arthritis.

Amgen is seeking approval for a significant new biosimilar that may soon hit the US market.

Last week, a Biologics License Application (BLA) was submitted to the FDA for ABP 501, which is biosimilar to adalimumab (Humira). This represents the first biosimilar application for Humira to be submitted to the FDA, and is also the manufacturer’s first BLA submission via the 351(k) biosimilar pathway, according to Amgen.

"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, MD, 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 an anti-TNF-α monoclonal antibody that has been approved in numerous regions for various inflammatory diseases. The active ingredient carries the same amino acid sequence and the same pharmaceutical dosage form and strength as Humira, according to Amgen.

The BLA submission followed a series of phase 3 studies that compared the efficacy and safety of ABP 501 in the treatment of both moderate-to-severe plaque psoriasis and moderate-to-severe rheumatoid arthritis. The primary endpoints were met in these studies, which showed clinical equivalence to Humira.

The trials also showed the safety and immunogenicity of ABP 501 is comparable to Humira. Amgen included data that supports transitioning patients on a Humira regimen to ABP 501.

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