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FDA News Release

FDA approves Inflectra, a biosimilar to Remicade

For Immediate Release

April 5, 2016

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The U.S. Food and Drug Administration today approved Inflectra (infliximab-dyyb) for multiple indications. Inflectra is administered by intravenous infusion. This is the second biosimilar approved by the FDA.

Inflectra is biosimilar to Janssen Biotech, Inc.’s Remicade (infliximab), which was originally licensed in 1998. Inflectra is approved and can be prescribed by a health care professional for the treatment of:

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

Health care professionals are advised to review the prescribing information (labeling) for detailed information about the approved uses.

“Biosimilars can provide access to important treatment options for patients who need them,” said Janet Woodcock, M.D., director of FDA’s Center for Drug Evaluation and Research. “Patients and the health care community can be confident that biosimilar products are high quality and meet the agency’s rigorous scientific standards.” 

Biological products are generally derived from a living organism. They can come from many sources, including humans, animals, microorganisms or yeast.

A biosimilar product is a biological product that is approved based on a showing that it is highly similar to an already-approved biological product, known as a reference product. The biosimilar also must show it has no clinically meaningful differences in terms of safety and effectiveness from the reference product. Only minor differences in clinically inactive components are allowable in biosimilar products.

A biosimilar product can only be approved by the FDA if it has the same mechanism(s) of action (but only to the extent that the mechanism(s) of action are known for the reference product), route(s) of administration, dosage form(s) and strength(s) as the reference product, and only for the indication(s) and condition(s) of use that have been approved for the reference product. The facilities where biosimilars are manufactured must also meet the FDA’s standards.

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, such as sinus infections and sore throat, headache, coughing 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. The drug must be dispensed with a patient Medication Guide that describes important information about its uses and risks. 

Inflectra is manufactured by Celltrion, Inc, based in Yeonsu-gu, Incheon, Republic of Korea, for Hospira, of Lake Forest, Illinois. Remicade is marketed by Janssen Biotech, Inc., based in Horsham, Pennsylvania.  

About the Biologics Price Competition and Innovation Act of 2009
The Biologics Price Competition and Innovation Act of 2009 (BPCI Act) was passed as part of the Affordable Care Act that President Obama signed into law in March 2010. The BPCI Act created an abbreviated licensure pathway for biological products shown to be “biosimilar” to or “interchangeable” with an FDA-licensed biological product, called the “reference product.” This abbreviated licensure pathway under section 351(k) of the Public Health Service Act permits reliance on certain existing scientific knowledge about the safety and effectiveness of the reference product, and enables a biosimilar biological product to be licensed based on less than a full complement of product-specific preclinical and clinical data.

The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.

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