FDA to review Amgen's Humira biosimilar

The FDA has accepted for review Amgen's Biologics License Application (BLA) for ABP 501, a biosimilar candidate to AbbVie’s Humira (adalimumab), with a decision due by September 25, 2016.

Amgen submitted the BLA in November last year, based on trial data in patients with moderate-to-severe plaque psoriasis and moderate-to-severe rheumatoid arthritis. The Phase III studies met their primary endpoints showing clinical and safety equivalence to adalimumab.

Amgen says it has included data to support the transition of adalimumab patients to ABP 501 are included in the submission.

"If approved, we believe ABP 501 could serve as an important additional approved therapeutic option for patients with chronic inflammatory conditions," says Sean Harper, executive vice president of research and development at Amgen. "We look forward to potentially expanding our robust portfolio of approved products, and further demonstrating our continued commitment to delivering high-quality medicines to patients worldwide."

The regulatory pathway to biosimilar approval in the US has historically been somewhat more complicated than that in Europe and other global locations. The first biologically similar drug - Sandoz’ Zarxio - was only approved by the FDA last March- almost a decade behind Europe’s first medicine of this kind.

Biosimilars offer payers savings on a smaller scale to traditional generic drugs, usually in the region of 15-30%, but cash-strapped healthcare systems will increasingly be turning to such products as they search for efficiencies.

Joel Levy