News

Hulio, Humira Biosimilar, Approved But Not Available Until 2023

The U.S. Food and Drug Administration (FDA) has approved Hulio, a biosimilar of Humira (adalimumab), to treat chronic inflammatory disorders such as ankylosing spondylitis. However, Hulio (adalimumab-fkjp) — developed by Mylan and Fujifilm Kyowa Kirin Biologics — will not be available in the U.S. until July 31,…

CHMP Favors At-home Injection Form of Remsima for Europe

The Committee for Medicinal Products for Human Use (CHMP), a branch of the European Medicines Agency (EMA), is recommending the use of a subcutaneous (under the skin) injection formulation of Remsima (infliximab) by people with ankylosing spondylitis and four other disorders. Celltrion Healthcare designed this new version…

Cosentyx Approved in US to Treat Active nr-axSpA

Cosentyx (secukinumab) has been approved in the U.S. to treat people with active non-radiographic axial spondyloarthritis (nr-axSpA), its developer, Novartis, has announced. The approval by the U.S. Food and Drug Administration (FDA) follows a similar decision by the European Commission in April. In both the…

FDA Approves Taltz for Non-radiographic Axial Spondyloarthritis

Eli Lilly‘s Taltz (ixekizumab) has been approved in the U.S. to treat non-radiographic axial spondyloarthritis (nr-axSpA) in people who have objective signs of inflammation. “This approval reflects Lilly’s continued growth and commitment to supporting rheumatologists and people with autoimmune conditions, including nr-axSpA,” Patrik Jonsson, senior vice president…