EMA accepts application for etanercept biosimilar

Biosimilares/Novedades | Posted 15/01/2016 post-comment0 Post your comment

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).

Application V15a16

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.

Related articles
FDA accepts application for pegfilgrastim biosimilar 

Biosimilars approved in the US

Biosimilars of pegfilgrastim

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  

Permission granted to reproduce for personal and non-commercial use only. All other reproduction, copy or reprinting of all or part of any ‘Content’ found on this website is strictly prohibited without the prior consent of the publisher. Contact the publisher to obtain permission before redistributing.

Copyright – Unless otherwise stated all contents of this website are © 2016 Pro Pharma Communications International. All Rights Reserved.

Source: Novartis, Sandoz

comment icon Comments (0)
Post your comment
Related content
La FDA aprueba el biosimilar pegfilgrastim Stimufend
Approved-V13G05
Biosimilares/Novedades Posted 07/10/2022
Most viewed articles
Sobre GaBI
INICIO/Sobre GaBI Posted 06/08/2009
EU guidelines for biosimilars
EMA logo 1 V13C15
INICIO/Directrices Posted 08/10/2010