The U.S. Food and Drug Administration gives approval to Inflectra (infliximab-dyyb) for multiple medical indications. The drug is the knockoff version of Remicade, which is from Johnson & Johnson's Janssen Biotech, Inc.
Doctors may now prescribe Inflectra for a variety of medical conditions such as arthritis and Crohn's disease, among many others. However, the agency still recommends professionals to review the information on the drug label for a more detailed explanation of its approved uses.
Inflectra is a biosimilar of Remicade, which was first licensed in 1998. In February, an FDA advisory panel recommended approval of another infliximab drug called Remsima.
Indication Of Inflectra
The FDA has given the nod to giving Inflectra to patients suffering from an array of illnesses including moderate to severe Crohn's disease for patients aged 6 years old and above, who no longer benefits from common therapy.
Inflectra may also be given to those with moderate to severe ulcerative colitis that cannot be relieved by conventional treatments anymore.
Patients experiencing moderate to severe rheumatoid arthritis may also use Inflectra together with another drug called methotrexate.
Inflectra may also be prescribed to patients with active arthritis of the spine, psoriatic arthritis and long-time severe plaque psoriasis.
Helpful Reminders Before Administration
The FDA mentions some common side effects expected from patients who will take Inflectra. These include headache, abdominal pain, cough, sore throat and sinus infections.
Inflectra is administered via intravenous infusion and reactions to the drug may be noted within two hours. Infusion reactions include fever, chest pain, shortness of breath, chills, rashes and low or high blood pressure.
Other more serious side effects of Inflectra include liver damage, blood disorder and in some cases, nervous system problems.
Inflectra comes with a Boxed Warning that notes how lymphoma and other malignancies have been documented in children and teenagers given products like infliximab. The Boxed Warning also includes information about the increased risk of hospital admissions, deaths and other diseases such as tuberculosis and fungal infections.
The FDA orders that Inflectra be dispensed with a medication guide that identifies vital information about its uses and risks.
Process Of Approval
FDA approved Inflectra on the basis of evidence review. Such evidences included animal study results, human study findings and clinical safety properties, among other technical pharmacological data that demonstrates the likeness of Inflectra and Remicade. After all, Inflectra was approved as a biosimilar of Remicade, and not an interchangeable drug.
Biosimilars: What Are They?
Biosimilar is a product that has been approved based on its high similarity to an already approved material termed as a reference product. Biosimilars need to showcase no clinically significant difference to the safety and effectiveness of its reference products. If there would be differences, it would only be applicable for clinically inactive ingredients of the product.
FDA only approves a drug to be a legit biosimilar if it has the same mechanism of action, route of administration, dosage and strength. Biosimilars will also only be approved for the same indications as its reference products. The FDA also looks into the facilities where the biosimilars are produced.
"Biosimilars can provide access to important treatment options for patients who need them," says FDA's Dr. Janet Woodcock. She adds that patients and the health community can be at ease that biosimilars possess high quality and have passed FDA's intricate scientific standards.