2016-04-07 18:08:34 UTC

FDA Approves New Biosimilar for IBD Patients

April 11, 2016

The biosimilar version of Remicade was approved for moderate to severe Crohn's disease and ulcerative colitis patients.

FDA has approved a new biosimilar version of the drug Remicade® (infliximab), making it the second biosimilar to receive approval. The decision came two months after the FDA Arthritis Advisory Committee voted 21 to three to recommend approval of the biosimilar. The new product, originally developed by South Korean company Celltrion, will be marketed by Pfizer under the brand name InflectraTM. The European Commission approved licensure in September 2013.  

FDA approved Inflectra for the following conditions:

  • Adult and pediatric patients age six and older with moderate to severe 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.  

An announcement released by FDA noted that the decision to approve Inflectra was based on evidence including structural and functional characterization, animal study data, human pharmacokinetic and pharmacodynamics data, and clinical immunogenicity data. The approval does not give the drug interchangeability status, which is a higher level of review than for biosimilarity.  

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