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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