The U.S. Food and Drug Administration today approved Inflectra (infliximab-dyyb) for multiple indications. Inflectra is administered by intravenous infusion. This is the second biosimilar approved by the FDA.

Inflectra is biosimilar to Janssen Biotech, Inc.’s Remicade (infliximab), which was originally licensed in 1998. Inflectra is approved and can be prescribed by a health care professional for the treatment of:
?adult patients and pediatric patients (ages six years and older) with moderately to severely active Crohn’s disease who have had an inadequate response to conventional therapy;
?adult patients with moderately to severely active ulcerative colitis who have had an inadequate response to conventional therapy;
?patients with moderately to severely active rheumatoid arthritis in combination with methotrexate;
?patients with active ankylosing spondylitis (arthritis of the spine);
?patients with active psoriatic arthritis;
?adult patients with chronic severe plaque psoriasis.

Health care professionals are advised to review the prescribing information (labeling) for detailed information about the approved uses.

For the detailed information, please check the link below.

http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm494227.htm