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2 Sep 2016

USFDA approves 3rd biosimilar: Erelzi, a biosimilar to Enbrel

The U.S. Food and Drug Administration today approved Erelzi, for multiple inflammatory diseases.
Erelzi is a biosimilar to Enbrel (etanercept), which was originally licensed in 1998.
Erelzi is manufactured by Sandoz Inc., based in Princeton, New Jersey, at Novartis Pharma in Stein, Switzerland. Enbrel is manufactured by Amgen Inc., of Thousand Oaks, California.
Erelzi is administered by injection for the treatment of:
  • moderate to severe rheumatoid arthritis, either as a standalone therapy or in combination with methotrexate (MTX);
  • moderate to severe polyarticular juvenile idiopathic arthritis in patients ages two and older;
  • active psoriatic arthritis, including use in combination with MTX in psoriatic arthritis patients who do not respond adequately to MTX alone;
  • active ankylosing spondylitis (an arthritis that affects the spine); and
  • chronic moderate to severe plaque psoriasis in adult patients (18 years or older) who are candidates for systemic therapy or phototherapy

The FDA’s approval of Erelzi 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 Erelzi is biosimilar to Enbrel. Erelzi has been approved as a biosimilar, not as an interchangeable product.

Erelzi 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, 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 etanercept products. The drug must be dispensed with a patient Medication Guide that describes important information about its uses and risks.

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