BioCentury
ARTICLE | Clinical News

Renflexis regulatory update

April 27, 2017 9:06 PM UTC

FDA approved a BLA from Samsung Bioepis Co. Ltd. for Renflexis infliximab-abda, a biosimilar of Remicade infliximab, to treat Crohn's disease (CD), ulcerative colitis (UC), rheumatoid arthritis (RA), ankylosing spondylitis, psoriatic arthritis and plaque psoriasis. The biosimilar will be available in the U.S. following a 180-day notice period as outlined in the Biologics Price Competition and Innovation Act (BPCIA)...