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Biosimilars of infliximab Posted 13/02/2015

Last update: 20 July 2018

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 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 September 2013 [4]. Remsima also has marketing approval in Brazil [5], Colombia, Japan, South Korea [6] and Venezuela [7]. Approved in Canada in January 2014 [8]. Approved in Australia in August 2015 [9]. Approved in Russia as Flammegis on 13 July 2015 [10]. Approved by FDA on 5 April 2016 [11]. Received approval to start clinical trials in China from CFDA in May 2017 [12]

Ixifi
(PF‑06438179)

Pfizer filed for approval with FDA in April 2017 and received approval for Ixifi in December 2017 [13]

Epirus Biopharmaceuticals*, USA

Infimab

‘Similar biologic’ approved in India in September 2014 [14]

MabTech/Sorrento Therapeutics, China*/USA

STI-002

Positive phase III trial for copy biological in China reported in January 2016 [15]

Nichi-Iko Pharmaceutical,  Japan

NI-071

Phase III trial in rheumatoid arthritis expected to be completed in March 2015 [16]. Approved in Japan in September 2017 [17]. US phase III trial in rheumatoid arthritis expected to be completed February 2019 [17]

Nippon Kayaku, Japan

Infliximab BS

Biosimilar approved in Japan in November 2014 [18]

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 [19]

Samsung Bioepis (Biogen/Samsung)/Merck [20], South Korea/USA

Flixabi/Renflexis (SB2)

Biosimilar approved in EU in May 2016 [21]. Approved in Korea as Renflexis in December 2015 [22]. Approved by Australia’s TGA in November 2016 [23]. Approved by FDA in April 2017 [24]

Sandoz, Switzerland

Zessly (PF‑06438179)

Phase I trial completed November 2013 [25]. Phase III trial in rheumatoid arthritis expected to be completed September 2017 [15]. Sandoz acquired EEA rights from Pfizer in February 2016 [26]. Approved by EC in May 2018 [27].

EEA: European Economic Area, this area includes the 28 EU Member States, plus Iceland, Liechtenstein and Norway; EC: European Commission; EU: European Union; EMA: European Medicines Agency; FDA: US Food and Drug Administration; TGA: Therapeutic Goods Administration; CFDA: China 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 approved by FDA on 5 April 2016 [11]. 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 [27]. Remsima will be distributed in Belgium, Germany, Italy, Luxembourg, The Netherlands and the UK exclusively by Mundipharma International and its independent associated companies [28]. Pfizer also received approval for Ixifi (PF‑06438179) from FDA in December 2017 [13].

South Korea-based Samsung Bioepis and its partner Merck gained approval for their infliximab biosimilar, Flixabi/Renflexis (SB2), from Australia’s TGA in November 2016 [23] and from FDA in April 2017 [24]. Sandoz received European Commission approval for its infliximab biosimilar, Zessly (PF‑06438179), in May 2018 [27].

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
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Source: EMA, Johnson & Johnson, Merck

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