Home / Reports / Clinical programmes for anti-TNF biosimilars

Clinical programmes for anti-TNF biosimilars Posted 14/08/2015

Biosimilars for anti-tumour necrosis factor (anti-TNF) drugs are currently under development. These include biosimilars of blockbusters such as AbbVie’s Humira (adalimumab), Amgen’s Enbrel (etanercept) and Johnson & Johnson’s Remicade (infliximab).

The drugs are used to treat autoimmune diseases, such as rheumatoid, juvenile rheumatoid and psoriatic arthritis, plaque psoriasis and ankylosing spondylitis, by inhibiting TNF; a soluble inflammatory cytokine.

For these biosimilars there are very clear requirements, analogous to originator endpoints and originator companies have failed to significantly innovate away [1].

Anti-TNF biosimilars makers are also adding ‘features’ to their clinical programmes to enable differentiation: additional indication trials, crossover trials, larger patient populations and trial location strategies.

Pivotal trials for anti-TNF 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.

In the following series of three articles the pivotal clinical trials being carried out for adalimumab, etanercept and infliximab biosimilars are presented.

Related articles
 Pivotal clinical trials for infliximab biosimilars

Pivotal clinical trials for etanercept biosimilars

Pivotal clinical trials for adalimumab biosimilars

Reference
1. Gal R. Biosimilars: at the inflection point. 13th EGA-European Biosimilars Group Conference; 23–24 April 2015; London, UK.

Permission granted to reproduce for personal and non-commercial use only. All other reproduction, copy or reprinting of all or part of any ‘Content’ found on this website is strictly prohibited without the prior consent of the publisher. Contact the publisher to obtain permission before redistributing.

Copyright – Unless otherwise stated all contents of this website are © 2015 Pro Pharma Communications International. All Rights Reserved. 

Comments (0)