Biologics License Application Accepted for Remicade Biosimilar

The FDA accepted for review a Biologics License Application (BLA) for SB2 (infliximab), a potential investigational biosimilar of Remicade, which treats rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis, Crohn's disease, plaque psoriasis, and ulcerative colitis.

As part of its partnership with Merck, this is the first BLA filed in the United States by Samsung Bioepis. The application seeks approval to use infliximab in all therapeutic indications that are approved for Remicade.

“The acceptance of this biosimilar application by the US FDA is an exciting milestone in the progression of our collaboration with Samsung Bioepis,” said Dora Bibila, general manager of Merck Biosimilars. “If approved, SB2 would offer an important therapeutic option to help meet the needs of US physicians, patients and the healthcare system in the treatment of certain serious inflammatory diseases.”