Amgen files for FDA approval of Humira biosimilar

Amgen announced a filing with the FDA for ABP 501, a biosimilar candidate to AbbVie's Humira (adalimumab). The company said it believes that the submission, made via the 351(k) biosimilar pathway, is the first Humira biosimilar application filed with the agency.

"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," commented Sean E. Harper, executive vice president of R&D at Amgen.

The drugmaker noted that its filing includes results from Phase III comparative efficacy and safety studies conducted in both moderate-to-severe plaque psoriasis and moderate-to-severe rheumatoid arthritis. Amgen said that the trials met their main goals, showing clinical equivalence to Humira, while the safety and immunogenicity of ABP 501 were also comparable to AbbVie's product. In addition, data to support the transition of Humira patients to ABP 501 have been included in the submission.

According to Amgen, the active ingredient of ABP 501 is an anti-TNF-alpha monoclonal antibody that has the same amino acid sequence as Humira. The drugmaker added that ABP 501 has the same pharmaceutical dosage form and strength as AbbVie's therapy. Annual sales of Humira reached $12.5 billion last year.

For related analysis, read Spotlight On: Will AbbVie's 'new Humira' strategy protect it against biosimilar competition? For more information on biosimilars, see Biosimilars: Regulatory Outlook.

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