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FDA Approves Remicade Biosimilar, Inflectra

Product is second biosimilar to win agency nod

The FDA has approved infliximab-dyyb (Inflectra, Celltrion, Inc.) for multiple indications. The product is biosimilar to infliximab (Remicade, Janssen Biotech), which was originally licensed in 1998. This is the second time the FDA has cleared a biosimilar product.

Infliximab-dyyb is indicated for the treatment of:

  • Adult and pediatric patients (6 years of age and older) with moderately to severely active Crohn’s disease who have shown an inadequate response to conventional therapy.
  • Adult patients with moderately to severely active ulcerative colitis who have shown an inadequate response to conventional therapy.
  • Patients with moderately to severely active rheumatoid arthritis in combination with methotrexate.
  • Patients with active ankylosing spondylitis.
  • Patients with active psoriatic arthritis.
  • Adult patients with chronic severe plaque psoriasis.

Biological products are generally derived from living organisms. They can come from many sources, including humans, animals, micro-organisms, or yeast.

A biosimilar is a biological product that is approved based on data showing that it is highly similar to an already-approved biological product, known as a reference product. The biosimilar also must show that it has no clinically meaningful differences in terms of safety and efficacy from the reference product. Only minor differences in clinically inactive components are allowable in biosimilar products.

Biosimilar products can be approved by the FDA only if they have the same mechanisms of action (but only to the extent that the mechanisms of action are known for the reference product), routes of administration, and dosage forms and strengths as the reference product, and only for the indications and conditions of use that have been approved for the reference product. The facilities where biosimilars are manufactured must also meet the FDA’s standards.

The approval of infliximab-dyyb was based on a review of evidence that included structural and functional characterization, animal study data, human pharmacokinetic and pharmacodynamic data, clinical immunogenicity data, and other clinical safety and efficacy data, which demonstrated that infliximab-dyyb is biosimilar to infliximab. Infliximab-dyyb has been approved as a biosimilar, not as an interchangeable product.

The most common adverse events associated with infliximab-dyyb include respiratory infections (such as sinus infections and sore throat), headache, coughing, and stomach pain. Infusion reactions can occur up to two hours after an infusion. The symptoms of infusion reactions include fever, chills, chest pain, hypotension, hypertension, shortness of breath, rash, and itching.

The labeling for infliximab-dyyb includes a boxed warning alerting health care professionals and patients about an increased risk of serious infections leading to hospitalization or death, including tuberculosis, bacterial sepsis, and invasive fungal infections (such as histoplasmosis). The boxed warning also notes that lymphoma and other malignancies, some fatal, have been reported in children and adolescent patients treated with tumor necrosis factor (TNF) blockers, including infliximab products such as Inflectra. Other serious adverse events may include liver injury, blood problems, lupus-like syndrome, psoriasis, and (in rare cases) nervous system disorders. Infliximab-dyyb must be dispensed with a medication guide that describes important information about its uses and risks.

Source: FDA; April 5, 2016.

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