Large Molecule

FDA Panel to Review Amgen's Humira Biosimilar

Source: Zacks

Jun 14, 2016

Amgen announced that the FDA’s Arthritis Advisory Committee will be reviewing data supporting the company's biologics license application for ABP 501, the biosimilar version of AbbVie's top-seller, Humira.

A final decision reagarding approval from the FDA is expected September 25 of this year. Amgen currently has nine biosimilar candidates in its portfolio and is hoping to launch its first biosimilar in 2017 followed by four others through 2019.

AbbVie's Humira recorded worldwide sales of $14 billion in 2015 and, as of last year, was the best-selling branded drug in the United States.

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