The U.S. Food and Drug Administration has approved Erelzi (etanercept-szzs), a biosimilar to the already licensed drug Enbrel (etanercept), for the treatment of multiple inflammatory diseases, including psoriasis.
Erelzi may be used as an injection therapy for people with active psoriatic arthritis, either as a monotherapy or in combination with methotrexate (MTX) in patients who do not respond adequately to MTX alone. Adults with chronic moderate to severe plaque psoriasis who are eligible for systemic therapy or phototherapy may also be treated with Erelzi.
“The biosimilar pathway is an important mechanism to improve access to treatment for patients with rheumatic and autoimmune diseases,” Janet Woodcock, MD, director of the FDA’s Center for Drug Evaluation and Research, said in the 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.”
The biosimilar is also approved to treat rheumatoid arthritis as a monotherapy or in combination with MTX, and for polyarticular juvenile idiopathic arthritis. It may also treat for patients with active ankylosing spondylitis, an arthritis that affects the spine.
A biosimilar product is a biological product with high similarity to an already-approved biological product, without meaningful differences in terms of safety and effectiveness, and meeting all the other required criteria. Biologics are products generally derived from a living organism, which can include humans, animals, microorganisms, or yeast.
Erelzi was approved after reviewing the evidence about its structural and functional biosimilarity to Enbrel demonstrated in animal studies, human pharmacokinetic and pharmacodynamics studies, clinical immunogenicity and other clinical safety and effectiveness studies.
Patients with sepsis cannot use Erelzi. The drug’s most severe side effects are neurologic events, hematologic events, congestive heart failure, and infections. Its most common possible adverse effects are injection site reactions and infections.
Healthcare professionals and patients are warned in the Boxed Leaflet about an increased risk of serious infections that can lead to tuberculosis, or invasive fungal infections like histoplasmosis. The warning also highlights that malignancies have been registered in patients who received tumor necrosis factor blockers like etanercept products.
Sandoz, the generic pharmaceuticals division of Novartis, manufactures Erelzi. Enbrel, first approved in 1998 to treat moderately to severely active rheumatoid arthritis, is made by Amgen.
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