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