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Breaking News, Trials & Filings

Sandoz Begins Global Testing of Humira Biosimilar

Adds to anti-inflammatory biosimilar portfolio

By: Gil Roth

President, Pharma & Biopharma Outsourcing Association

Sandoz has begun a Phase III clinical trial with its biosimilar version of AbbVie‘s Humira (adalimumab). This is Sandoz’s eighth Phase III trial initiation for a biosimilar and its sixth biosimilar to reach that stage. Sandoz is also conducting Phase III trials of biosimilars for Amgen’s Enbrel and Roche/Genentech’s Rituxan/MabThera.

The study is intended to demonstrate equivalent efficacy, similarity, and immunogenicity of Sandoz’s product versus Humira in patients with moderate to severe plaque-type psoriasis. The trial spans 12 countries across Europe, the U.S. and Asia, including Japan.

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