FDA to review data on Amgen’s Humira biosimilar
pharmafile | June 14, 2016 | News story | Manufacturing and Production, Research and Development, Sales and Marketing | Amgen, FDA, Humira, biosimilar
Amgen (NASDAQ: AMGN) has announced the US Food and Drug Administration’s (FDA) Arthritis Advisory Committee will review data supporting the company’s biologics license application (BLA) for their biosimilar candidate for blockbuster drug Humira (adalimumab).
The FDA accepted the license application from Amgen in January for ABP 501, with a decision due by September 25 2016 at the very latest.
As part of their regulatory submission, Amgen has provided analytical, clinical and pharmacokinetic data from Phase III comparative efficacy and safety studies for ABP 501 versus Humira in plaque psoriasis and rheumatoid arthritis. These late-stage trials managed to meet their primary endpoints showing clinical equivalence to adalimumab.
Sean E. Harper, executive VP of R&D, says: “With our heritage in both rheumatology and dermatology, we are committed to providing physicians and patients a variety of biologic options, which are critical for the long-term management of these serious diseases. We look forward to discussing the comprehensive data package for ABP 501 with the members of the Committee.”
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.
Sean Murray
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