Sandoz launches Phase III trial of biosimilars of AbbVie’s Humira

Sandoz, the generics unit of Swiss drug major Novartis (NOVN: VX), has initiated a Phase III clinical trial with its biosimilar version of US drugmaker AbbVie’s (NYSE: ABBV) Humira (adalimumab).

Humira, the leading treatment of several autoimmune conditions including rheumatoid arthritis, psoriasis, and Crohn's disease, has overtaken Pfizer’s now off-patent Lipitor (atorvastatin) as the world’s best-selling drug, with 2013 sales expected to exceed $10 billion and forecast to reach $13 billion in 2016, the end of which the drug starts losing patent protection.

This is Sandoz's eighth Phase III trial initiation across six compounds and aims to demonstrate equivalent efficacy, similarity, and immunogenicity of the Sandoz product versus Humira in patients with moderate to severe plaque-type psoriasis. Psoriasis affects approximately 3% of the world's population with between nine and 30% percent of patients with severe psoriasis receiving no treatment at all.