FDA Gives Nod to Erelzi, Biosimilar Version of Etanercept (Enbrel)

Biologic product treats inflammatory diseases

The FDA has approved etanercept-szzs (Erelzi, Sandoz) for several inflammatory diseases. The product is a biosimilar to etanercept (Enbrel, Amgen), which was originally licensed in 1998.

Etanercept-szzs is administered by injection for the treatment of:

  • Moderate-to-severe rheumatoid arthritis, either as a stand-alone therapy or in combination with methotrexate (MTX)
  • Moderate-to-severe polyarticular juvenile idiopathic arthritis in patients 2 years of age 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
  • Chronic moderate-to-severe plaque psoriasis in adult patients (18 years of age and older) who are candidates for systemic therapy or phototherapy

Biologic products are generally derived from a living organism and can come from many sources, including humans, animals, microorganisms, or yeast. A biosimilar is a biologic product that is approved based on evidence that it is highly similar to an already-approved biologic product and has no clinically meaningful differences in terms of safety and efficacy from the reference product, in addition to meeting other criteria specified by law.

The FDA’s approval of etanercept-szzs is based on evidence that included structural and functional characterization, animal study data, human pharmacokinetic and pharmacodynamics data, clinical immunogenicity data, and other clinical safety and efficacy data demonstrating that etanercept-szzs is biosimilar to etanercept. Etanercept-szzs has been approved as a biosimilar, not as an interchangeable product.

The most serious adverse effects of etanercept-szzs include infections, neurological events, congestive heart failure, and hematological events. It should not be administered to patients with sepsis.

The labeling for etanercept-szzs includes 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 (TNF) blockers, including etanercept products. The drug must be dispensed with a patient medication guide that describes important information about its uses and risks.

Source: FDA; August 30, 2016.