What is the difference between Erelzi and Enbrel?
Erelzi (etanercept-szzs) is a biosimilar for the reference product Enbrel (etanercept).
Erelzi is the first FDA approved biosimilar for etanercept.
A biosimilar is a biological product that is “highly similar” to a U.S.-licensed reference biological (in this case Enbrel). The FDA has determined there are no clinically meaningful differences between the biological product Erelzi and the original reference product Enbrel in terms of safety, purity, and potency. A biosimilar is not considered a “generic” in the same way that a traditional drug is determined to be a generic. Erelzi is not an interchangeable product with Enbrel at the pharmacy. Physicians must write the prescription specifically for Erelzi, as pharmacists cannot automatically substitute Erelzi for Enbrel.
What is etanercept?
Etanercept is a tumor necrosis factor (TNF) blocker that was first approved under the brand name Enbrel. TNF is a naturally occurring cytokine that is involved in normal inflammatory and immune responses. Etanercept reduces the effect of TNF and reduces inflammation.
Biosimilars to Enbrel include Erelzi (etanercept-szzs) and Eticovo (etanercept-ykro).
What is Erelzi used for?
Erelzi is used for the same five indications found on Enbrel product labeling:
- rheumatoid arthritis
- polyarticular juvenile idiopathic arthritis (JIA) in patients 2 years of age or older
- psoriatic arthritis
- ankylosing spondylitis
- plaque psoriasis in patients 4 years of age or older.
How are Erelzi and Enbrel administered?
Erelzi and Enbrel are administed via subcutaneous injection.
- Erelzi is available as a single-dose prefilled syringe and a single-dose prefilled Sensoready® Pen.
- Enbrel is available as a single-dose prefilled syringe, a single-dose prefilled SureClick® Autoinjector, a single dose vial, a multiple-dose vial for reconstitution, and Enbrel Mini® single dose prefilled cartridge for use with the AutoTouch® reusable autoinjector.
Related Questions
References
- US Food and Drug Administration (FDA). ENBREL® Product Label. Available at https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/103795s5574s5577lbl.pdf [Accessed February 16, 2021]
- US Food and Drug Administration (FDA). ERELZITM Product Label. Available at https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/761042s012lbl.pdf [Accessed February 16, 2021]
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