FDA Approves First Biosimilar to Enbrel
The Food and Drug Administration (FDA) has approved Erelzi (etanercept-szzs; Sandoz) injection, a biosimilar to Enbrel (etanercept; Amgen).
Erelzi is indicated for the treatment of 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 ages ≥2 years; 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 (≥18 years) who are candidates for systemic therapy or phototherapy.
Biological products are typically derived from a living organism, including humans, animals, microorganisms or yeast. A biosimilar product is a biological product that is approved based on a demonstration that it is highly similar to an already-approved biological product with no clinically meaningful differences in safety and efficacy from the reference product.
The approval of Erelzi was supported by review of evidence that included structural and functional characterization, animal study data, human pharmacokinetic (PK) and pharmacodynamics data, clinical immunogenicity data, and other clinical safety and efficacy data that showed Erelzi was biosimilar to Enbrel. Clinical studies included 4 comparative PK studies in 216 subjects, and a confirmatory efficacy and safety similarity study in 513 subjects.
Erelzi carries a Boxed Warning regarding an increased risk of serious infections leading up to hospitalization or death, including tuberculosis, invasive fungal infections (eg, histoplasmosis), and others. In addition, lymphoma and other malignancies (some fatal) have been reported in children and adolescent patients treated with tumor necrosis factor blockers, including etanercept products.
Erelzi is not approved as an interchangeable product for Enbrel. Erelzi will be available as single-dose 50mg/mL prefilled syringes in 1- and 4-count cartons, as 50mg/mL single-dose prefilled Sensoready Pens in 1- and 4-count cartons, and as 25mg/0.5mL single-dose prefilled syringes in 1- and 4-count cartons.
For more information call (800) 525-8747 or visit Erelzi.com.