FDA Approves Biosimilar of Johnson and Johnson’s Blockbuster Drug Remicade

The FDA approved Inflectra (infliximab-dyyb, Celltrion, Inc), a biosimilar to Remicade (infliximab, Johnson & Johnson), for the treatment of multiple conditions including rheumatoid arthritis and inflammatory bowel diseases. This is only the second biosimilar to be approved in the US.

Infliximab-dyyb is indicated for the treatment of moderate to severe active Crohn’s disease in adult and pediatric patients who have an inadequate response to conventional therapy; moderate to severe active ulcerative colitis in adult patients who have had an inadequate response to conventional therapy; severe active rheumatoid arthritis in combination with methotrexate; active ankylosing spondylitis; active psoriatic arthritis; and chronic severe plaque psoriasis in adults.

Infliximab-dyyb is not approved as an interchangeable product. Approval as a biosimilar was 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,” according to the FDA.

The most common expected side effects include respiratory infections, headache, coughing, and stomach pain.

Infliximab-dyyb is administered by intravenous infusion. Symptoms of infusion reactions include fever, chills, chest pain, low blood pressure or high blood pressure, shortness of breath, rash, and itching. These symptoms can occur up to 2 hours after infusion.

Infliximab-dyyb has a boxed warning for an increased risk of serious infections including tuberculosis, bacterial sepsis, invasive fungal infections, and others. In children and adolescent patients treated with tumor necrosis factor blockers, including infliximab products, lymphoma and other malignancies, some fatal, have been reported. Serious side effects include liver injury, blood problems, lupus-like syndrome, psoriasis, and, in rare cases, nervous system disorders. Infliximab-dyyb comes with a patient Medication Guide outlining information regarding use and risks.

Reference

FDA approves Inflectra, a biosimilar to Remicade [press release]. FDA.gov. April 6, 2016.