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Biosimilars of infliximab Posted 13/02/2015

Last update: 29 November 2019

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, before the advent of biosimilars, see Table 1.

The patents on Remicade expired in the US in September 2018 and 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 

BioXpress Therapeutics, Switzerland

-

Biosimilar in pipeline 

Celltrion/Hospira (Pfizer), South Korea/USA

Remsima/Inflectra/  Flammegis
(CT-P13)

IV version approved in EU in September 2013 . SC version approved by EC in September 2019 [2]. Remsima also has marketing approval in Brazil [ 3], Colombia, Japan, South Korea [ 4] and Venezuela [ 5]. Approved in Canada in January 2014 [ 6]. Approved in Australia in August 2015 [ 7]. Approved in Russia as Flammegis in July 2015 [ 8]. Approved by FDA in April 2016 [ 9]. Received approval to start clinical trials in China from CFDA in May 2017 

Ixifi
(PF‑06438179)

Pfizer received FDA approval for Ixifi in December 2017 [ 9]

Epirus Biopharmaceuticals*, USA

Infimab

‘Similar biologic’ approved in India in September 2014 [10]

MabTech/Sorrento Therapeutics, China*/USA

STI-002

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

Nichi-Iko Pharmaceutical,  Japan

NI-071

Phase III trial in rheumatoid arthritis expected to be completed in March 2015 . Approved in Japan in September 2017 [4]. US phase III trial in rheumatoid arthritis expected to be completed February 2019

Nippon Kayaku, Japan

Infliximab BS

Biosimilar approved in Japan in November 2014 [4]

Ranbaxy Laboratories/Epirus Biopharmaceuticals, India*/USA

BOW015

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

Samsung Bioepis (Biogen/Samsung)/Merck (MSD), South Korea/USA

Flixabi (EU)/Renflexis (US) (SB2)

Biosimilar approved in EU in May 2016 [ 2]. Approved in Korea as Renflexis in December 2015 [11]. Approved by Australia’s TGA in November 2016 [ 7]. Approved by FDA in April 2017 [9]

Sandoz, Switzerland

Zessly (PF‑06438179)

Sandoz acquired EEA rights from Pfizer in February 2016. Approved by EC in May 2018 [2]

Shanghai Biomabs Pharmaceuticals, China*

Baimaibo

Phase III trial in RA in China started March 2018

CFDA: China Food and Drug Administration; EC: European Commission; EEA: European Economic Area, this area includes the 28 EU Member States, plus Iceland, Liechtenstein and Norway; EMA: European Medicines Agency; EU: European Union; FDA: US Food and Drug Administration; RA: rheumatoid arthritis; TGA: Therapeutic Goods Administration.

*See editor’s comment

Celltrion/Hospira received approval for the IV version of their infliximab biosimilar (Remsima/Inflectra) in Europe in September 2013 [4] and for the subcutaneous version, Remsima SC, in November 2019 [2]. Inflectra was approved by FDA on 5 April 2016 [9]. Celltrion and Hospira’s infliximab biosimilar (Remsima/Inflectra) has been approved by the EMA for the same indications as Remicade (inflixmab), i.e., ankylosing spondylitis, Crohn’s disease, psoriasis, psoriatic arthritis, rheumatoid arthritis and ulcerative colitis [2]. Remsima will be distributed in Belgium, Germany, Italy, Luxembourg, The Netherlands and the UK exclusively by Mundipharma International and its independent associated companies [12]. Pfizer also received approval for Ixifi (PF‑06438179) from FDA in December 2017 [9].

Editor’s comment
It should be noted that ‘similar biologics’ approved in India and ‘copy biologicals’ approved in China 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 biologicals: 2018 update. Generics and Biosimilars Initiative Journal (GaBI Journal). 2019;8(1):24-31. doi:10.5639/gabij.2019.0801.003 
2. 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
3. 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
4. GaBI Online - Generics and Biosimilars Initiative. Biosimilars approved in Japan [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [2019 Nov 29]. Available from: www.gabionline.net/Biosimilars/General/Biosimilars-approved-in-Japan
5. 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
6. GaBI Online - Generics and Biosimilars Initiative. Biosimilars approved in Canada [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2017 Nov 10]. Available from: www.gabionline.net/Biosimilars/General/Subsequent-entry-biologics-approved-in-Canada
7. GaBI Online - Generics and Biosimilars Initiative. Biosimilars approved in Australia [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2017 Nov 10]. Available from: www.gabionline.net/Biosimilars/General/Biosimilars-approved-in-Australia
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. Biosimilars approved in the US [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2016 Aug 26]. Available from: www.gabionline.net/Biosimilars/General/Biosimilars-approved-in-the-US
10. GaBI Online - Generics and Biosimilars Initiative. ‘Similar biologics’ approved and marketed in India [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2017 Nov 10]. Available from: www.gabionline.net/Biosimilars/General/Similar-biologics-approved-and-marketed-in-India
11. 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
12. GaBI Online - Generics and Biosimilars Initiative. Infliximab biosimilar to be distributed by Mundipharma [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2019 Nov 29]. 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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