A Second Biosimilar Has Been Approved in the United States, a Follow-on to Infliximab

The FDA has approved infliximab-dyyb as a biosimilar and not as an interchangeable biological.

The FDA has approved Inflectra (infliximab-dyyb), administered as an intravenous infusion, for multiple indications. This is biosimilar to Janssen Biotech’s Remicade (infliximab). The approval comes just over a year after the first biosimilar product, Zarxio (filgrastim-sndz), was approved by the FDA.

The indications for this second biosimilar product in the United States include:

  • Adult patients and pediatric patients (ages 6 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

The approval followed an FDA review of structural and functional data, animal study data, human pharmacokinetic and pharmacodynamics data, clinical immunogenicity data, and other clinical safety and effectiveness data of infliximab-dyyb. The review convinced the FDA that infliximab-dyyb is biosimilar to infliximab. It is important to note that infliximab-dyyb has not been approved as an interchangeable product.

Janet Woodcock, MD, director of FDA’s Center for Drug Evaluation and Research said in a statement, “Biosimilars can provide access to important treatment options for patients who need them. Patients and the health care community can be confident that biosimilar products are high quality and meet the agency’s rigorous scientific standards.”

The cost of infliximab-dyyb will of course be an important factor that could significantly impact acceptance. A single infusion of infliximab can cost anywhere between $1300 and $2500. Unless the biosimilar is sold at a significantly lower price, shifting consumer preference could be a challenge, especially since providers and patients alike have been cautious with accepting biosimilars.

Infliximab-dyyb is manufactured by Celltrion, Inc, based in the Republic of Korea, for Hospira. It will be marketed in the United States by Pfizer.