First Biosimilar Etanercept Approved for Multiple Inflammatory Diseases

The FDA has approved Novartis’s etanercept-szzs (Erelzi), a biosimilar to Amgen’s etanercept (Enbrel), for the treatment of several inflammatory diseases.

Erelzi can be administered via injection for all indications included in the reference product’s label, such as:

· 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 2 years 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; and

· Chronic moderate to severe plaque psoriasis in adult patients who are candidates for systemic therapy or phototherapy.

For detailed information about Erelzi’s approved uses, health care professionals should review the prescribing information in the biosimilar’s labeling.

The FDA approved Erelzi as a biosimilar for these uses after reviewing 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 demonstrated Erelzi is biosimilar to Enbrel. A biosimilar is a biological product approved based on a showing that it is highly similar to an already-approved biological product and has no clinically meaningful differences in terms of safety and effectiveness from the reference product, in addition to meeting other criteria specified by law. Notably, Erelzi has not been approved 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.

The most serious side effects associated with Erelzi are infections, congestive heart failure, neurologic events, and hematologic events. More common side effects are infections and injection site reactions. Of note, Erelzi should not be administered to patients with sepsis.