The FDA has approved Inflectra, a biosimilar to Remicade (infliximab) for multiple indications, having determined that the biosimilar is equivalent in efficacy and safety to the original tumor necrosis factor (TNF) inhibitor.
"Biosimilars can provide access to important treatment options for patients who need them," said , who directs the FDA's Center for Drug Evaluation and Research, .
"Patients and the healthcare community can be confident that biosimilar products are high quality and meet the agency's rigorous scientific standards," she said.
The biosimilar, which has the generic name infliximab-dyyb, is approved for several indications, including moderate to severe rheumatoid arthritis in combination with methotrexate, active ankylosing spondylitis, active psoriatic arthritis, and chronic, severe plaque psoriasis in adults. Its approved label can be .
Inflectra, which is manufactured by the Korean firm and will be marketed and sold by Pfizer, can also be used for adults and children 6 years and older who have moderately to severely active Crohn's disease that has not responded to conventional treatment, and for adults with moderately to severely active ulcerative colitis that has been unresponsive to standard treatments.
Inflectra is the second biosimilar to be given the FDA nod. The agency previously approved Zarxio for the prevention of chemotherapy-associated infections among cancer patients.
The American College of Rheumatology issued a statement on biosimilars last year, indicating that a biosimilar can have "no clinically meaningful differences in terms of safety, purity, and potency" compared with the reference product. The college also noted that it was unacceptable for patients who are stable on a biologic to be switched to a substitute simply as a cost-saving measure unless the providing clinician provides prior consent.
Adverse effects that can occur with Inflectra are the same as with infliximab and include respiratory infections, headache, and infusion reactions. The product's labeling includes a boxed warning about an increased risk of serious infections, and states that lymphomas and other malignancies have been reported in children and adolescents treated with TNF inhibitors.