BASEL (dpa-AFX) - Sandoz, a Novartis (NVS) division, said Tuesday that the US Food and Drug Administration approved Erelzi or etanercept-szzs for all indications included in the reference product label, including rheumatoid arthritis or RA, plaque psoriasis or PsO,psoriatic arthritis or PsA, ankylosing spondylitis or AS and polyarticular juvenile idiopathic arthritis or JIA.
Erelzi is the second biosimilar from Sandoz approved in the US through the FDA biosimilars pathway established under the Biologics Price Competition and Innovation Act.
An application for Sandoz biosimilar etanercept has been accepted by the European Medicines Agency and is currently undergoing review.
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 should not be administered to patients with sepsis.
The most serious known side effects with Erelzi are infections, neurologic events, congestive heart failure and hematologic events. The most common expected adverse reactions with Erelzi are infections and injection site reactions.
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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