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Biotech Stocks Facing FDA Decision In September

Amgen
Amgen

Amgen Inc.'s (AMGN) ABP 501, a biosimilar candidate to AbbVie's Humira, awaits FDA’s final decision on September 25, 2016.

In July of this year, an FDA advisory panel of outside experts voted 26-0 in favor of recommending approval of ABP 501. The FDA usually follows the recommendations of its advisory panels, although it is not required to do so.

AbbVie's Humira is approved to reduce the signs and symptoms of moderate to severe rheumatoid arthritis in adults, moderate to severe polyarticular juvenile idiopathic arthritis in children 2 years of age and older, psoriatic arthritis in adults, ankylosing spondylitis in adults, moderate to severe Crohn's disease in adults and children, moderate to severe hidradenitis suppurativa in adults, moderate to severe ulcerative colitis and moderate to severe chronic plaque psoriasis in adults.

Humira raked in sales of $14 billion in 2015, and was the world’s best-selling drug of the year.