FDA approves biosimilar etanercept Erelzi

Biosimilars/News | Posted 23/09/2016 post-comment0 Post your comment

The US Food and Drug Administration (FDA) announced on 30 August 2016 that it had approved Sandoz’s biosimilar version of Amgen/Pfizer’s arthritis blockbuster Enbrel (etanercept).


The news follows the positive recommendation of FDA’s Arthritis Advisory Committee in July 2016, which voted unanimously (20−0) in favour of the recommendation to approve the etanercept biosimilar (GP2015) in all five indications of the originator product (Enbrel) [1].

Etanercept is a biological drug that treats autoimmune diseases by inhibiting tumour necrosis factor (TNF); a soluble inflammatory cytokine. Etanercept is indicated for the treatment of rheumatoid, juvenile rheumatoid and psoriatic arthritis, plaque psoriasis and ankylosing spondylitis. Rheumatoid arthritis and psoriasis are estimated to affect around 1.3 million and 7.5 million people, respectively, in the US.

FDA’s approval of the etanercept biosimilar, which will be called Erelzi (etanercept-szzs), is based on review of evidence that included structural and functional characterization, animal study data, human pharmacokinetic and pharmacodynamics data, clinical immunogenicity data and other clinical safety and effectiveness data that demonstrates Erelzi is biosimilar to Enbrel. Erelzi has been approved as a biosimilar, not as an interchangeable product. According to the Biologics Price Competition and Innovation Act, only a biological that has been approved as interchangeable may be substituted for the reference product without the intervention of the healthcare provider who prescribed the reference product.

Erelzi is the second biosimilar from Sandoz approved in the US through the FDA biosimilars pathway. Sandoz’s filgrastim biosimilar Zarxio (filgrastim-sndz), was the first product approved in the US as a biosimilar back in 2015 [2].

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1. GaBI Online - Generics and Biosimilars Initiative. FDA advisors recommend approval of Sandoz’s etanercept biosimilar [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2016 Sept 23]. Available from: www.gabionline.net/Biosimilars/News/FDA-advisors-recommend-approval-of-Sandoz-s-etanercept-biosimilar
2. GaBI Online - Generics and Biosimilars Initiative. FDA approves its first biosimilar [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2016 Sept 23]. Available from: www.gabionline.net/Biosimilars/News/FDA-approves-its-first-biosimilar

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Source: Novartis, US FDA

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