FDA approves Humira biosimilar, Hulio
The U.S. Food and Drug Administration (FDA) has approved adalimumab-fkjp (Hulio; Mylan/Fujifilm Kyowa Kirin), a biosimilar to adalimumab (Humira; AbbVie), for the treatment of rheumatoid arthritis, juvenile idiopathic arthritis, psoriatic arthritis, ankylosing spondylitis, adult Crohn’s disease, ulcerative colitis and plaque psoriasis, according to a press release.
This is the sixth biosimilar to Humira the FDA has approved.
“We are very pleased with FDA’s approval of Hulio, a biosimilar to the world’s top selling drug Humira, which will help bring another treatment option to U.S. patients living with chronic inflammatory conditions. This approval represents yet another date-certain launch opportunity and demonstration of our commitment to expand patients’ access to medicine thanks to the power of our global platform, including our global reach and scale, our continued demonstration of scientific excellence, and the benefits of strategic partnerships, such as the one we are proud to have with Fujifilm Kyowa Kirin Biologics. With one of the industry’s largest and most diverse global biosimilars franchises, Mylan is committed to improving patient access to this and other critically important biologic medicines as well as providing more affordable treatment options for patients worldwide,” said Rajiv Malik, President of Mylan, in a press release.
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