New biosimilar for RA to save millions
FDA’s approval of a new biosimilar—the third FDA-approved biosimilar—stands to save the US healthcare system millions of dollars.
FDA recently gave the green light to etanercept-szzs (Erelzi, Sandoz), a biosimilar to Amgen’s top-selling Enbrel for rheumatoid arthritis, plaque psoriasis and other inflammatory conditions. Enbrel netted sales of $5.1 million in the United States last year, according to Fortune.
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“The biosimilar pathway is an important mechanism to improve access to treatment for patients with rheumatic and autoimmune diseases,” Janet Woodcock, MD, director of FDA’s Center for Drug Evaluation and Research, said in an FDA press release. “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.”
Back in July, FDA's Arthritis Advisory Committee (AAC) made a unanimous decision to recommend use in all indications of the reference product. The approval is based on a comprehensive package of analytical, nonclinical, and clinical data confirming that Erelzi is highly similar to the US-licensed reference product, according to the manufacturer.
Clinical studies included 4 comparative pharmacokinetic (PK) studies in 216 healthy volunteers and a confirmatory efficacy and safety similarity study in 531 patients with chronic plaque psoriasis. Extrapolation to all indications approved for use on the reference product label is on the basis that the Sandoz biosimilar etanercept and the reference product are essentially the same.
In addition, application for Sandoz’s biosimilar etanercept is under review by the European Medicines Agency.
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 healthcare 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.