Posted by Michael Wonder on 24 Jul 2019
Merck's biosimilar to AbbVie's Humira wins FDA approval
24 July 2019 - The U.S. FDA approved Merck & Co Inc’s biosimilar to AbbVie's blockbuster rheumatoid arthritis treatment Humira, the health agency said on Tuesday.
The drug, Hadlima, is manufactured by Samsung Bioepis for Merck and comes with a boxed warning, the FDA's harshest. The agency flagged increased risk of serious infections, including tuberculosis and bacterial sepsis.
