Erelzi, a biosimilar of Enbrel (etanercept), has received FDA approval. Biosimilars are defined by the organization as being â€œhighly similar to an FDA-approved biological productâ€ while demonstrating â€œclinically meaningful differences in terms of safety and effectiveness.â€
Erelzi (etanercept-szzs), manufactured by the Sandoz branch of Novartis and a biosimilar Amgen’s Enbrel (etanercept), has received FDA approval. Biosimilars are defined by the organization as being “highly similar to an FDA-approved biological product” while demonstrating “clinically meaningful differences in terms of safety and effectiveness.”
Etanercept, an injectable treatment, is approved for inflammatory conditions like ankylosing spondylitis, plaque psoriasis, and psoriatic and rheumatoid arthritis. It is a tumor necrosis factor (TNF) inhibitor that works by mitigating the immune responses that cause much of the painful inflammation in such conditions.
Janet Woodcock, M.D., of the FDA’s Center for Drug Evaluation and Research, says that the regulatory body carefully evaluates biosimilars alongside their reference dugs, and that, “Patients and providers can have confidence that there are no clinically meaningful differences in safety and efficacy from the reference product.”
A litany of studies have been conducted on the efficacy and safety of entanercept since it was first licensed in 1998. A 2007 study found that patients receiving biweekly injections of etanercept over the course of almost 2 years saw psoriasis improvement roughly on par with placebo, with no adverse side effects. A 2011 study found that monitored some rheumatoid arthritis patients for over a decade found it safe over that time period and effective in reducing inflammation and pain. Multiple studies have found it effective for treating juvenile arthritis.
Like Enbrel itself, Erelzi will carry a Boxed Warning of “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...”