Biosimilar Erelzi gains FDA approval | Courtesy of Shutterstock
+ Regulatory
Amanda Rupp | Sep 3, 2016

Biosimilar Erelzi gains FDA approval

Leaders with the U.S. Food and Drug Administration (FDA) recently approved Erelzi, a biosimilar to Enbrel, as a treatment for multiple inflammatory diseases within the U.S.

Now, Erelzi injections are approved to treat moderate to severe rheumatoid arthritis, both as a combination with methotrexate (MTX) or a standalone therapy.

The new drug is also approved to treat active psoriatic arthritis, even if patients are using MTX but not finding relief; moderate to severe polyarticular juvenile idiopathic arthritis, for patients two years old and above; chronic moderate to severe psoriasis, for patients who are 18 years old and above and qualify for systemic therapy or phototherapy; and active ankylosing spondylitis, an arthritis damaging the spine.

Biological products are taken from a living organism, whether it’s animals, humans, yeast or microorganisms. This type is chosen because it demonstrates a similarity to already-approved biological products without any clinically meaningful differences in efficacy and safety from the other biosimilar product.

“The biosimilar pathway is an important mechanism to improve access to treatment for patients with rheumatic and autoimmune diseases,” Dr. Janet Woodcock, director of the FDA’s Center for Drug Evaluation and Research, said. “We carefully evaluate the structural and functional characteristics of these complex molecules. Patients and providers can have confidence that there are no clinically meaningful differences in safety and efficacy from the reference product.”

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