It is the first application filed in the US by Samsung Bioepis as part of its alliance with Merck to provide biosimilar alternatives to existing biologic medicines.
Samsung is seeking approval for use in all therapeutic indications currently approved for Remicade for which marketing exclusivity has expired.
Merck Biosimilars general manager Dora Bibila said: "The acceptance of this biosimilar application by the U.S. FDA is an exciting milestone in the progression of our collaboration with Samsung Bioepis.
"If approved, SB2 would offer an important therapeutic option to help meet the needs of U.S. physicians, patients and the healthcare system in the treatment of certain serious inflammatory diseases."
Under the development and commercialization agreement signed in February 2013, Merck will commercialize several biosimilar candidates in several partnered territories.
Samsung Bioepis will oversee preclinical and clinical development, process development and manufacturing, clinical trials and regulatory registration.
Merck will be responsible for commercialization of approved products that arise from the deal.
Remicade is a chimeric monoclonal antibody biologic drug that works against tumour necrosis factor alpha and is used for the treatment of autoimmune diseases.
The FDA approved remicade to treat Crohn’s disease, ulcerative colitis, psoriasis, psoriatic arthritis, ankylosing spondylitis, and rheumatoid arthritis.