Author Archives: Forest Ray PhD

FDA Gives Thumbs-up for Phase 2 Trial of Izokibep in AS Patients

The U.S. Food and Drug Administration (FDA) has cleared the start of a Phase 2 trial of izokibep in people with ankylosing spondylitis (AS), according to the therapy’s developers Affibody AB and Inmagene Biopharmaceuticals. “Obtaining FDA IND [investigational new drug] clearance is an important milestone for the izokibep…

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,…