FDA Approves Inflectra, a Biosimilar to Remicade

And then there were two ... The U.S. Food and Drug Administration approved the biosimilar Inflectra (infliximab-dyyb) for multiple indications.

Inflectra is biosimilar to Janssen Biotech, Inc.’s Remicade (infliximab), which was originally licensed in 1998.  This is the second biosimilar approved by the FDA. Inflectra is administered by intravenous infusion. The biosimilar is manufactured by Celltrion, Inc, based in Yeonsu-gu, Incheon, Republic of Korea, for Hospira, of Lake Forest, Illinois.

Inflectra can be prescribed by a health care professional for the treatment of:

• patients with active psoriatic arthritis;
• adult patients with chronic severe plaque psoriasis;
• 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)

The FDA’s 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. Inflectra has been approved as biosimilar, not as an interchangeable product.

The most common expected side effects of Inflectra include respiratory infections and stomach pain. Infusion reactions can happen up to two hours after an infusion. Symptoms of infusion reactions may include fever, chills, chest pain, low blood pressure or high blood pressure, shortness of breath, rash and itching. 

Inflectra contains a Boxed Warning to alert health care professionals and patients about an increased risk of serious infections leading to hospitalization or death, including tuberculosis, bacterial sepsis, invasive fungal infections (such as histoplasmosis) and others. 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 blockers, including infliximab products such as Inflectra.

Other serious side effects may include liver injury, blood problems, lupus-like syndrome, psoriasis, and in rare cases nervous system disorders.

Health care professionals are advised to review the prescribing information.