FDA Approves Inflectra

April 5, 2016

Biosimilars Team

FDA Approves Inflectra

The Food and Drug Administration (FDA) has announced the approval of Inflectra (infliximab-dyyb), the second biosimilar approved in the United States.  Inflectra is biosimilar to Remicade (infliximab; Janssen Biotech, Inc.), which was licensed in 1998. Inflectra has not been approved as an interchangeable product.

Inflectra is administered by intravenous infusion.  It is approved for all indications:

  • Adult patients and pediatric patients (6 years of age 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.

Inflectra is manufactured by Celltrion, Inc, for Hospira, now a Pfizer company. Pfizer holds exclusive commercialization rights to Inflectra in the United States and certain other jurisdictions.  Marketing of Inflectra is expected in 2016 but ultimately will depend on a number of factors that include marketplace dynamics and intellectual property considerations.

Sources

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

http://www.pfizer.com/news/press-release/press-release-detail/fda_approves_inflectra_biosimilar_infliximab_the_first_u_s_biosimilar_monoclonal_antibody_for_all_eligible_indications