FDA approves biosimilar ‘Inflectra’ for treatment of Rheumatoid Arthritis

On April 5th, 2016, the FDA announced its approval for Inflectra, a biosimilar, for the treatment of Rheumatoid Arthritis as well as other indications. It is approved for treatment in moderate to severe Rheumatoid Arthritis in combination with methotrexate.

Inflectra is what the industry and regulators are calling “biosimilar” to Janssen Biotech Inc.’s Remicade, which was first approved in 1998.

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

While biologics are generally derived from living organisms like humans, animals, yeast, or microorganisms, biosimilars are a close copy of biotech drugs.1 A biosimilar is approved based on showing that is highly similar to an already approved biological product, also known as a reference product.2 Therefore, a biosimilar must show that it has no clinically meaningful differences when it comes to safety and effectiveness when compared to the its reference product.

The FDA approves a biosimilar only when it is proven that it has the same mechanism of action, route(s) of administration, dosage form(s) and strength(s) as its reference product. Inflectra will be administered via infusions, just like its reference product Remicade. While Inflectra has been approved as a biosimilar of Remicade, it cannot be used as an interchangeable product with Remicade.

Common side effects of Inflectra include respiratory infections, such as sinus infections and sore throat, headache, coughing and stomach pain. There could be symptoms of infusion reactions which may include fever, chills, chest pain, low blood pressure or high blood pressure, shortness of breath, rash and itching.

Inflectra also comes with a Boxed Warning to alert healthcare professionals and patients that there could be an increased risk of serious infections which could lead to hospitalization or death, including tuberculosis, bacterial sepsis, invasive fungal infections (like, histoplasmosis), and others. The Boxed Warning also includes that lymphoma and other malignancies, sometimes fatal, have also been reported in children and adolescent patients that have been treated with tumor necrosis factor blockers, including infliximab products such as Inflectra. Liver injury, blood problems, lupus-like syndrome, psoriasis, and nervous system disorders (in rare cases) are some other serious side effects that could occur with Inflectra use.

The exact timeframe, when Inflectra will be available for market use has not yet been determined.

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