FDA Staff Says Amgen Biosimilar is 'Highly Similar' to AbbVie's Blockbuster Humira
Amgen Inc's biosimilar form of AbbVie Inc's Humira arthritis drug, the world's top-selling medicine, is similarly potent and safe as the original product, according to a preliminary review by staff members of the U.S. Food and Drug Administration.
The assessment precedes an all-day meeting on Tuesday of an independent panel of medical advisers who will decide whether to recommend approval of Amgen's cheaper version of Humira, called ABP 501. In two large Amgen-sponsored studies, the company said it showed similar effectiveness to Humira.
In documents posted on the FDA's website on Friday, staff scientists said their review of data from those trials and other studies suggested ABP 501 and Humira are "highly similar" in their safety, purity and potency in the studied indications of rheumatoid arthritis and plaque psoriasis.
The assessment precedes an all-day meeting on Tuesday of an independent panel of medical advisers who will decide whether to recommend approval of Amgen's cheaper version of Humira, called ABP 501. In two large Amgen-sponsored studies, the company said it showed similar effectiveness to Humira.
In documents posted on the FDA's website on Friday, staff scientists said their review of data from those trials and other studies suggested ABP 501 and Humira are "highly similar" in their safety, purity and potency in the studied indications of rheumatoid arthritis and plaque psoriasis.