Pivotal clinical trials for infliximab biosimilars

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Pivotal clinical trials for infliximab biosimilars

Home/Reports | Posted 11/09/2015 3 Post your comment

Biosimilars of Johnson & Johnson’s blockbuster arthritis drug Remicade (infliximab), a chimeric monoclonal antibody against tumour necrosis factor alpha (TNF-α), are currently under development.

Infliximab treats autoimmune diseases such as ankylosing spondylitis, Crohn’s disease, psoriasis, psoriatic arthritis, rheumatoid arthritis and ulcerative colitis.

Pivotal trials for candidate infliximab biosimilars being carried out typically include one in rheumatoid arthritis and one in psoriasis, each including around 500 patients and taking less than two years [1], see Table 1.

Table 1: Pivotal clinical trials for candidate infliximab biosimilars

Study ID	Product name	Company name, country	Phase	Trial design	Status	No. of subjects	Start/end dates	Primary outcome(s)
Crohn’s disease
NCT02096861	Remsima/ Inflectra Approved EU Sep 2013 [2]	Celltrion/Hospira, South Korea/USA	III	4-arm, parallel: 2 continuous, 2 cross-over	Recruiting	214	Jul 2014/Mar 2017	CDAI-70
Rheumatoid arthritis
NCT01217086 PLANETRA	Remsima/ Inflectra (CT-P13) Approved EU Sep 2013 [2]	Celltrion/Hospira, South Korea/USA	III	2-arm, parallel	Completed	617	Oct 2010/ Jul 2012	PK equivalence
NCT01571219	Remsima/Inflectra (CT-P13) Approved EU Sep 2013 [2]	Celltrion/Hospira, South Korea/USA	III	1-arm (extension study)	Completed	302	Mar 2012/Jul 2013	Long-term efficacy ACR
NCT01927263	NI-071	Nichi-Iko, Japan	III	2-arm, parallel	Active, not recruiting	230	Jul 2013/ Mar 2015	DAS28-ESR
2013-004148-49/NCT02222493	PF-06438179	Pfizer, USA	III	2-arm, parallel	Recruiting	614	Aug 2014/Sep 2017	ACR20
NCT01936181	SB2	Samsung Bioepis, South Korea	III	4-arm, parallel, cross-over	Active, not recruiting	584	Aug 2013/ Aug 2014	ACR20
ACR20: 20% improvement in ACR (American College of Rheumatology) core set measurements; CDAI-70: Crohn's disease activity index -70 response; DAS28-ESR: Disease Activity Score for 28 joints - erythrocyte sedimentation rate; PK: pharmacokinetic.

The originator product, Johnson & Johnson’s Remicade (infliximab), was approved by the US Food and Drug Administration in August 1998 and by the European Medicines Agency in August 1999. The patents on Remicade expire in the US in September 2018 and in Europe in February 2015 [3]. Remicade had sales of US$6.9 billion in 2014.

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References
1. Gal R. Biosimilars: at the inflection point. 13th EGA-European Biosimilars Group Conference; 23–24 April 2015; London, UK.
2. GaBI Online - Generics and Biosimilars Initiative. Biosimilars approved in Europe [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2015 Sep 11]. Available from: www.gabionline.net/Biosimilars/General/Biosimilars-approved-in-Europe
3. GaBI Online - Generics and Biosimilars Initiative. US$67 billion worth of biosimilar patents expiring before 2020 [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2015 Sep 11]. Available from: www.gabionline.net/Biosimilars/General/US-67-billion-worth-of-biosimilar-patents-expiring-before-2020

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Comments (3)

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Posted 15/03/2024 by Sun Research Institute

Clinical Research

Your insightful exploration of pivotal clinical trials for infliximab biosimilars is truly commendable! Your ability to distill complex research into a concise yet informative piece is both impressive and invaluable. Keep illuminating the path toward better healthcare options!

Posted 08/11/2023 by Anthika U, GaBI Online Editorial Office

Response to ‘Clinical trials’

Dear Sirs,
Thank you for your valuable comments received on 3 November 2023. We appreciate that you are letting us know, kindly continue with your valuable comments to GaBI Online.
Best Regards,
Anthika

Posted 03/11/2023 by Sun Research Institute

Clinical trials

Clinical trials play a pivotal role in advancing medical research and improving patient care. Sun Research Institute is at the forefront of these efforts, conducting groundbreaking trials that shape the future of healthcare. Their commitment to innovation and patient welfare is truly commendable. By participating in clinical trials, we can contribute to the development of life-changing treatments and therapies. It's a collective effort that benefits us all.