FDA approval of Infectra: A biosimilar to Remicade

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FDA approval of Infectra: A biosimilar to Remicade

The U.S. Food and Drug Administration (FDA) has announced the approval of Inflectra, the first biosimilar for Remicade (infliximab) for the treatment of multiple diseases, including rheumatoid arthritis and psoriatic arthritis and established that this new biosimilar is equivalent to the original tumor necrosis factor (TNF) inhibitor in terms of safety and efficacy.

According to Janet Woodcock, M.D., director of FDA’s Center for Drug Evaluation and Research, "Biosimilars can provide access to important treatment options for patients who need them. "She also added, "Patients and the healthcare community can be confident that biosimilar products are high quality and meet the agency's rigorous scientific standards."

The drug, given the generic name of infliximab-dyyb is indicated for the treatment of patients with a number of serious autoimmune diseases in combination with methotrexate, including Crohn's disease, ulcerative colitis, rheumatoid arthritis, ankylosing spondylitis, psoriatic arthritis and plaque psoriasis in adults.

Inflectra is made by Korea's Celltrion, will be marketed and sold by Pfizer. This drug can also be used to treat moderate to severe active Crohn's disease patients such as children 6 years, adults and older, have not responded well to conventional treatment. Furthermore, it is also demonstrated in adult patients who have been unresponsive to standard treatments to treat moderate to severe active ulcerative colitis. In fact, it is the second biosimilar approved in the U.S. The biosimilar Zarxio was previously released in year 2015 and approved by FDA for the prevention of chemotherapy induced infections complications in cancer patients.

The statement is issued on the behalf of the American College of Rheumatology (ACR) on biosimilars which showed that a product can be considered as biosimilar if it have "no clinically meaningful differences in terms of safety, purity, and potency" as compared with the reference product. The ACR also indicated that it is unacceptable for patients who are stable on a medication to be switched to a substitute simply as a cost-saving measure without the prior consent of the prescribing clinician.

The most commonly expected side effects include respiratory infections, headache and infusion reactions with Inflectra which are as same as with infliximab. In addition, biosimilar product labeling may include box warning indicates the increased risk of serious infections and states that lymphomas and other malignancies have been reported in children and adolescents treated with tumor necrosis factor (TNF) inhibitors.

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