FDA Approves Inflectra™, the Second US Biosimilar

April 7, 2016

On Tuesday, April 5th, FDA announced the approval of Inflectra™ (infliximab-dyyb), a biosimilar version of Janssen Biotech’s Remicade® (infliximab), for a number of indications.  Inflectra is manufactured by Celltrion and is a monoclonal antibody (mAb), or “immunoglobulin molecules (IgG, IgM, IgA, IgE) that are secreted from a population of identical cells (i.e., cloned cells).”  It is the second biosimilar product, and the first biosimilar mAb therapy, to receive US approval.

According to the FDA’s press release, “the approval of Inflectra is based on review of evidence that included structural and functional characterization, animal study data, human pharmacokinetic and pharmacodynamics data, clinical immunogenicity data and other clinical safety and effectiveness data that demonstrates Inflectra is biosimilar to Remicade.”  In addition, FDA emphasizes the fact that it has approved Inflectra as a biosimilar, not as an interchangeable product.

Inflectra was approved by FDA 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.”

As such, physicians can prescribe the product for any of the indications listed above and are advised to review the product’s labeling for additional information about the approved uses before prescribing Inflectra to patients.

Inflectra’s approval comes just more than a year after FDA approved the first US biosimilar, Zarxio® (filgrastim-sndz).  This marks a monumental event for the US biosimilar industry; it will be interesting to watch as additional biosimilar products continue to be introduced into the US pharmaceutical market.

Do you have a biosimilar or other FDA-regulated product in development?  We can help you develop your 315(k) BLA or any other FDA submission.  To learn more about how we can help you, contact us today.




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