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Biosimilars of infliximab Posted 13/02/2015

Last update: 6 January 2017

Infliximab is a chimeric monoclonal antibody against tumour necrosis factor alpha (TNF-α). It is used to treat autoimmune diseases, such as ankylosing spondylitis, Crohn’s disease, psoriasis, psoriatic arthritis, rheumatoid arthritis, and ulcerative colitis.

The originator product, Johnson & Johnson and Merck’s Remicade (infliximab), was approved by the US Food and Drug Administration (FDA) in August 1998 and by the European Medicines Agency (EMA) in August 1999 [1]. Remicade had worldwide sales of US$9.3 billion in 2014, making it the world’s best-selling medicine and a lucrative target for biosimilars developers, see Table 1.

The patents on Remicade will expire in the US in September 2018 and expired in Europe in February 2015 [1].  Some of the infliximab biosimilars and non-originator biologicals* approved or in development are presented in Table 1.

Table 1: Biosimilars and non-originator biologicals* of infliximab approved or in development

Company name, Country

Product name

Stage of development

Amgen, USA

ABP 710

Biosimilar in active development, according to Amgen’s Form 10-K for 2013 [2]

BioXpress Therapeutics, Switzerland

-

Biosimilar in pipeline [3]

Celltrion/Hospira (Pfizer), South Korea/USA

Remsima/Inflectra/ Flammegis (CT-P13)

Biosimilar approved in EU in Sept 2013 [4]. Remsima also has marketing approval in Brazil [5], Colombia, Japan, South Korea [6] and Venezuela [7]. Approved in Russia as Flammegis on 13 July 2015 [8]. Approved by FDA on 5 April 2016 [9]

MabTech/Sorrento Therapeutics, China*/USA

STI-002

Positive phase III trial for copy biological in China reported in January 2016 [10]

Nichi-Iko, Japan

NI-071

Phase III trial in rheumatoid arthritis expected to be completed in March 2015 [11]

Nippon Kayaku, Japan

Infliximab BS

Biosimilar approved in Japan in November 2014 [12]

Ranbaxy Laboratories/Epirus Biopharmaceuticals, India*/USA

BOW015

‘Similar biologic’ approved in India in December 2014 [13]. Global phase III trial expected to be completed in July 2017 [14]

Samsung Bioepis/Merck [15], South Korea/USA

Flixabi/Renflexis (SB2)

Biosimilar approved in EU in May 2016 [16]. Approved in Korea as Renflexis in December 2015 [17]. Submitted to FDA for approval in May 2016 [18]

Sandoz, Switzerland

PF-06438179

Phase I trial completed November 2013 [19]. Phase III trial in rheumatoid arthritis expected to be completed September 2017 [11]. Sandoz acquired EEA rights from Pfizer in February 2016 [20]

EEA: European Economic Area, this area includes the 28 EU Member States, plus Iceland, Liechtenstein and Norway; EU: European Union; EMA: European Medicines Agency; FDA: US Food and Drug Administration

*See editor’s comment

Celltrion/Hospira received approval for their infliximab biosimilar (Remsima/Inflectra) in Europe in September 2013 [4]. Inflectra was recommended for approval by FDA’s Arthritis Advisory Committee on 9 February 2016 [9].Celltrion and Hospira’s infliximab biosimilar (Remsima/Inflectra) has been approved by EMA for the same indications as Remicade (inflixmab), i.e. ankylosing spondylitis, Crohn’s disease, psoriasis, psoriatic arthritis, rheumatoid arthritis, and ulcerative colitis [21].

Editor’s comment
It should be noted that ‘similar biologics’ approved in India might not have been authorized following as strict a regulatory process as is required for approval of biosimilars in the European Union.  The EMA (European Medicines Agency) regulatory requirements ensure the same high standards of quality, safety and efficacy for biosimilars as for originator biologicals, and also include a rigorous comparability exercise with the reference product.

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References
1.   Derbyshire M. Patent expiry dates for best-selling biologicals. Generics and Biosimilars Initiative Journal (GaBI Journal). 2015;4(4):178-9. doi:10.5639/gabij.2015.0404.040
2.   GaBI Online - Generics and Biosimilars Initiative. Amgen expands biosimilars programme [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2015 Feb 13]. Available from: www.gabionline.net/Biosimilars/News/Amgen-expands-biosimilars-programme
3.   BioXpress Therapeutics, Biosimilar pipeline [homepage on the Internet]. [cited 2015 Feb 13]. Available from: www.bioxpress.com/#!pipeline/c6gz
4.   GaBI Online - Generics and Biosimilars Initiative. Biosimilars approved in Europe [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2015 Feb 13]. Available from: www.gabionline.net/Biosimilars/General/Biosimilars-approved-in-Europe
5.   GaBI Online - Generics and Biosimilars Initiative. Brazil approves first monoclonal antibody follow-on biological [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2015 Jun 26]. Available from: www.gabionline.net/Biosimilars/News/Brazil-approves-first-monoclonal-antibody-follow-on-biological
6.   GaBI Online - Generics and Biosimilars Initiative. Biosimilar infliximab receives approval in Japan and Turkey [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2015 Feb 13]. Available from: www.gabionline.net/Biosimilars/News/Biosimilar-infliximab-receives-approval-in-Japan-and-Turkey
7. GaBI Online - Generics and Biosimilars Initiative. Venezuelan approval for Celltrion’s Remsima [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2016 Aug 26]. Available from: www.gabionline.net/Biosimilars/News/Venezuelan-approval-for-Celltrion-s-Remsima
8. GaBI Online - Generics and Biosimilars Initiative. Non-originator infliximab approved in Russia [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2017 Jan 6]. Available from: www.gabionline.net/Biosimilars/News/Non-originator-infliximab-approved-in-Russia
9. GaBI Online - Generics and Biosimilars Initiative. FDA approves infliximab biosimilar Inflectra [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2016 Aug 26]. Available from: www.gabionline.net/Biosimilars/News/FDA-approves-infliximab-biosimilar-Inflectra
10.   GaBI Online - Generics and Biosimilars Initiative. Positive phase III results for cetuximab and rituximab copy biologicals [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2016 Mar 11]. Available from: www.gabionline.net/Biosimilars/Research/Positive-phase-III-results-for-cetuximab-and-infliximab-copy-biologicals
11.   GaBI Online - Generics and Biosimilars Initiative. Pivotal clinical trials for infliximab biosimilars [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2015 Oct 16]. Available from: www.gabionline.net/Reports/Pivotal-clinical-trials-for-infliximab-biosimilars
12.   GaBI Online - Generics and Biosimilars Initiative. Biosimilar infliximab launched in Japan [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2015 Feb 13]. Available from: www.gabionline.net/Biosimilars/News/Biosimilar-infliximab-launched-in-Japan
13.   GaBI Online - Generics and Biosimilars Initiative. ‘Similar biologics’ approved and marketed in India [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2015 Feb 13]. Available from: www.gabionline.net/Biosimilars/General/Similar-biologics-approved-and-marketed-in-India
14.   GaBI Online - Generics and Biosimilars Initiative. Epirus starts phase III trial for infliximab biosimilar [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2015 Feb 23]. Available from: www.gabionline.net/Biosimilars/News/Epirus-starts-phase-III-trial-for-infliximab-biosimilar
15. GaBI Online - Generics and Biosimilars Initiative. Merck outlines biosimilars programme [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2017 Jan 6]. Available from: www.gabionline.net/Biosimilars/News/Merck-outlines-biosimilars-programme
16. GaBI Online - Generics and Biosimilars Initiative. EMA recommends approval of infliximab biosimilar Flixabi [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2016 Aug 26]. Available from: www.gabionline.net/Biosimilars/News/EMA-recommends-approval-of-infliximab-biosimilar-Flixabi
17.   GaBI Online - Generics and Biosimilars Initiative. Korean approval for infliximab biosimilar [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2015 Mar 11]. Available from: www.gabionline.net/Biosimilars/News/Korean-approval-for-infliximab-biosimilar
18. GaBI Online - Generics and Biosimilars Initiative. Samsung Bioepis infliximab biosimilar accepted for review by FDA [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2016 Aug 26]. Available from: www.gabionline.net/Biosimilars/News/Samsung-Bioepis-infliximab-biosimilar-accepted-for-review-by-FDA
19. GaBI Online - Generics and Biosimilars Initiative. Phase I studies of infliximab and rituximab biosimilars demonstrate pharmacokinetic similarity [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2017 Jan 6]. Available from: www.gabionline.net/Biosimilars/Research/Phase-I-studies-of-infliximab-and-rituximab-biosimilars-demonstrate-pharmacokinetic-similarity
20. GaBI Online - Generics and Biosimilars Initiative. Sandoz acquires EU rights to infliximab biosimilar from Pfizer [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2017 Jan 6]. Available from: www.gabionline.net/Biosimilars/General/Sandoz-acquires-EEA-rights-to-infliximab-biosimilar-from-Pfizer
21.   GaBI Online - Generics and Biosimilars Initiative. Infliximab biosimilar to be distributed by Mundipharma [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2015 Feb 13]. Available from: www.gabionline.net/Biosimilars/News/Infliximab-biosimilar-to-be-distributed-by-Mundipharma

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Source: EMA, Johnson & Johnson, Merck

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