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FDA Accepts License Application for Humira Biosimilar

Approval decision expected in September

The FDA has accepted for review the biologics license application (BLA) for ABP 501 (Amgen), a biosimilar candidate to adalimumab (Humira, AbbVie).

The BLA, submitted on November 25, 2015, is based on analytical, clinical, and pharmacokinetic data. Phase 3 comparative efficacy and safety studies were conducted in both moderate-to-severe plaque psoriasis and moderate-to-severe rheumatoid arthritis. The phase 3 studies met their primary endpoints, showing clinical equivalence to adalimumab. The safety and immunogenicity of ABP 501 were also comparable with that of adalimumab. Data to support the transition of adalimumab patients to ABP 501 were included in the submission.

The FDA has set a Biosimilar User Fee Act (BsUFA) target action date of September 25, 2016.

The active ingredient in ABP 501 is an anti-tumor necrosis factor (TNF)-alpha monoclonal antibody that has the same amino acid sequence as adalimumab. ABP 501 also has the same pharmaceutical dosage form and strength as adalimumab.

Source: Amgen; January 25, 2016.

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