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FDA accepts application for etanercept biosimilar Posted 09/10/2015

Sandoz, the generics division of Novartis, announced on 2 October 2015 that the US Food and Drug Administration (FDA) had accepted its application for its etanercept biosimilar (GP2015).

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.

The product is a proposed biosimilar of Amgen/Pfizer’s arthritis blockbuster Enbrel (etanercept), which had sales of US$8.3 billion in 2014, making it one of the top selling biologicals. The patents on Enbrel will expire in the US in November 2028, after Amgen was granted a new patent, and expired in Europe in August 2015 [1, 2].

Sandoz believes that ‘the totality of evidence in its submission, including two pivotal clinical studies, will demonstrate that the proposed biosimilar is essentially the same as the reference product’. The company also believes that it is the first company to have an application for biosimilar etanercept accepted by FDA.

This is Sandoz’s second biosimilar application in the US. The company gained US approval for its filgrastim biosimilar, Zarxio (filgrastim-sndz), on 6 March 2015 [3]. Zarxio was the first biosimilar to be approved in the US.

Rival biosimilars maker Samsung Bioepis has already had an etanercept biosimilar (Brenzys) approved in South Korea [4] and had its application for its etanercept biosimilar candidate, SB4, accepted for review by the European Medicines Agency (EMA) in January 2015 [5].

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References
1. GaBI Online - Generics and Biosimilars Initiative. US$67 billion worth of biosimilar patents expiring before 2020 [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2015 Oct 9]. Available from: www.gabionline.net/Biosimilars/General/US-67-billion-worth-of-biosimilar-patents-expiring-before-2020
2. GaBI Online - Generics and Biosimilars Initiative. New Amgen Enbrel patent could block biosimilars until 2028 [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2015 Oct 9]. Available from: www.gabionline.net/Biosimilars/News/New-Amgen-Enbrel-patent-could-block-biosimilars-until-2028
3. GaBI Online - Generics and Biosimilars Initiative. Zarxio first biosimilar to be launched in US [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2015 Oct 9]. Available from: www.gabionline.net/Biosimilars/News/Zarxio-first-biosimilar-to-be-launched-in-US
4. GaBI Online - Generics and Biosimilars Initiative. Biosimilar approved in South Korea [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2015 Oct 9]. Available from: www.gabionline.net/Biosimilars/General/Biosimilars-approved-in-South-Korea
5. GaBI Online - Generics and Biosimilars Initiative. Biosimilar etanercept submitted for approval in EU [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2015 Oct 9]. Available from: www.gabionline.net/Biosimilars/News/Biosimilar-etanercept-submitted-for-approval-in-EU

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Source: Sandoz

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