BLA for Adalimumab Biosimilar Accepted for Review

FDA set a date of Sept. 25, '16, to complete the review
FDA set a date of Sept. 25, '16, to complete the review

Amgen announced that the Food and Drug Administration (FDA) has accepted for review the Biologics License Application (BLA) for ABP 501, a biosimilar candidate to Humira (adalimumab).

The BLA submission is based on analytical, pharmacokinetic, and clinical data, including Phase 3 comparative efficacy and safety studies of ABP 501 in patients with moderate-to-severe plaque psoriasis and moderate-to-severe rheumatoid arthritis. Data submitted to the FDA showed that ABP 501 is clinically equivalent to adalimumab, with comparable safety and immunogenicity profile. The Company also included data to support the transition of adalimumab patients to ABP 501. 

RELATED: Cancer, RA Biosimilars Demonstrated Efficacy in Phase 3 Trials 

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

ABP 501, a monoclonal antibody, is a tumor necrosis factor (TNF) blocker with the same amino acid sequence as adalimumab. It will also have the same pharmaceutical dosage form and strength as adalimumab. 

For more information call (800) 772-6436 or visit Amgen.com.

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