Swiss drugmaker Novartis International AG (NVS: Quote) said Thursday that its generic pharmaceuticals division, Sandoz, has initiated a Phase III clinical trial with its biosimilar version of adalimumab (AbbVie's HUMIRA) - the leading treatment of several autoimmune conditions including rheumatoid arthritis, psoriasis, and Crohn's disease. This is Sandoz's eighth Phase III trial initiation across six compounds.
According to the company, the aim of the study is to demonstrate equivalent efficacy, similarity, and immunogenicity of the Sandoz product versus HUMIRA in patients with moderate to severe plaque-type psoriasis. Sandoz is working closely with physicians and patients on this global trial, which spans 12 countries across Europe, the United States and Asia including Japan.
"Adalimumab will be a key building block in our growing Immunology portfolio, which includes other biosimilar candidates currently in Phase III trials such as etanercept (Amgen's Enbrel) and rituximab (Roche's Rituxan/MabThera)," said Ameet Mallik, Sandoz' Head of Biopharmaceuticals and Oncology Injecta
According to the company, the aim of the study is to demonstrate equivalent efficacy, similarity, and immunogenicity of the Sandoz product versus HUMIRA in patients with moderate to severe plaque-type psoriasis. Sandoz is working closely with physicians and patients on this global trial, which spans 12 countries across Europe, the United States and Asia including Japan.
"Adalimumab will be a key building block in our growing Immunology portfolio, which includes other biosimilar candidates currently in Phase III trials such as etanercept (Amgen's Enbrel) and rituximab (Roche's Rituxan/MabThera)," said Ameet Mallik, Sandoz' Head of Biopharmaceuticals and Oncology Injecta