LONDON, Dec 18 (Reuters) - Sandoz, the generics division of Novartis, said on Wednesday it had initiated a late-stage clinical trial with its so-called biosimilar version of AbbVie’s best-selling drug Humira.
It is Sandoz’s sixth copy of a biotech medicine to enter Phase III trials and could represent a major prize, since the Humira drug for rheumatoid arthritis, psoriasis, and Crohn’s disease is the world’s top-selling prescription product with sales of around $10 billion a year.
The trial will study patients with moderate to severe plaque-type psoriasis and is designed to support registration in the United States and Europe.
Creating copies of such antibody drugs is complicated because they are produced in living cells, bringing inevitable unpredictability. As a result, copies can only ever be “similar”, not exact replicas.