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EMA accepts application for etanercept biosimilar Posted 15/01/2016

Sandoz, the generics division of Novartis, announced on 8 December 2015 that the regulatory submission for its proposed etanercept biosimilar (GP2015) had been accepted by the European Medicines Agency (EMA).

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. More than 120 million people in the European Union (EU) are living with rheumatic and musculoskeletal diseases and approximately 3.7 million Europeans have psoriasis.

The product is a proposed biosimilar to Amgen/Pfizer’s Enbrel (etanercept), which had worldwide sales of US$8.3 billion in 2014. 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 is seeking approval for its biosimilar etanercept in the same indications as the reference product (Enbrel), which includes chronic inflammatory conditions like rheumatoid arthritis and psoriasis. Sandoz believes that the totality of evidence in its submission, which includes two pivotal clinical trials – a pharmacokinetic study in healthy volunteers and a confirmatory safety and efficacy study in patients with chronic plaque-type psoriasis (EGALITY) – will demonstrate that the proposed biosimilar is highly similar to the reference product.

Sandoz already has three biosimilars approved in the EU: Binocrit (epoetin alfa), Omnitrope (somatropin) and Zarzio (filgrastim) [3]. The company also gained US approval for its filgrastim biosimilar, Zarxio (filgrastim-sndz), in March 2015 [4] – the first biosimilar to be approved in the US. It has also submitted applications for approval of its etanercept (GP2015) and pegfilgrastim (LA-EP2006) biosimilars to the US Food and Drug Administration [5, 6].

Rival biosimilars maker Samsung Bioepis has already had an etanercept biosimilar (Brenzys) approved in South Korea [7] and had its application for its etanercept biosimilar candidate, SB4, accepted for review by EMA in January 2015 [8].

Sandoz currently has five biosimilars that are in phase III clinical trials or are undergoing registration, including adalimumab (for patients with autoimmune diseases). The company plans to make 10 regulatory filings over the three-year period from 2015 to 2017.

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References
1.  GaBI Online - Generics and Biosimilars Initiative. Biologicals patent expiries [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2016 Jan 15]. Available from: www.gabionline.net/Biosimilars/General/Biologicals-patent-expiries   
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 2016 Jan 15]. Available from: www.gabionline.net/Biosimilars/News/New-Amgen-Enbrel-patent-could-block-biosimilars-until-2028    
3.  GaBI Online - Generics and Biosimilars Initiative. Biosimilars approved in Europe [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2016 Jan 15]. Available from: www.gabionline.net/Biosimilars/General/Biosimilars-approved-in-Europe  
4.  GaBI Online - Generics and Biosimilars Initiative. Zarxio first biosimilar to be launched in US [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2016 Jan 15]. Available from: www.gabionline.net/Biosimilars/News/Zarxio-first-biosimilar-to-be-launched-in-US  
5.  GaBI Online - Generics and Biosimilars Initiative. FDA accepts application for etanercept biosimilar [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2016 Jan 15]. Available from: www.gabionline.net/Biosimilars/News/FDA-accepts-application-for-etanercept-biosimilar  
6.  GaBI Online - Generics and Biosimilars Initiative. FDA accepts application for pegfilgrastim biosimilar [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2016 Jan 15]. Available from: www.gabionline.net/Biosimilars/News/FDA-accepts-application-for-pegfilgrastim-biosimilar  
7.  GaBI Online - Generics and Biosimilars Initiative. Biosimilar approved in South Korea [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2016 Jan 15]. Available from: www.gabionline.net/Biosimilars/General/Biosimilars-approved-in-South-Korea  
8.  GaBI Online - Generics and Biosimilars Initiative. Biosimilar etanercept submitted for approval in EU [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2016 Jan 15]. Available from: www.gabionline.net/Biosimilars/News/Biosimilar-etanercept-submitted-for-approval-in-EU  

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Source: Novartis, Sandoz

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