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Sandoz Achieves Important Milestones on Phase III Trials for Key Biosimilars Programs
News

Sandoz Achieves Important Milestones on Phase III Trials for Key Biosimilars Programs

Sandoz Achieves Important Milestones on Phase III Trials for Key Biosimilars Programs
News

Sandoz Achieves Important Milestones on Phase III Trials for Key Biosimilars Programs

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Sandoz continues to advance its industry-leading biosimilars pipeline that currently has six molecules in the Phase III clinical trial/filing prep phase.

As part of the Novartis Q1 announcements, Sandoz has announced the following biosimilar development milestones:

• Sandoz completed the patient enrollment for its Phase III trial with biosimilar etanercept (Amgen's Enbrel®). The global clinical trial seeks to confirm biosimilarity with regard to safety, efficacy and immunogenicity of the Sandoz product versus Enbrel in patients with moderate to severe chronic plaque-type psoriasis.

• Sandoz also completed a Phase III trial for the US registration of biosimilar filgrastim (Amgen's Neupogen®) and two global Phase III trials for global registration of biosimilar pegfilgrastim (Amgen's Neulasta®). The trials aimed to confirm biosimilarity of the Sandoz biosimilars versus Neupogen® and Neulasta® in breast cancer patients eligible for myelosuppresive chemotherapy treatment.

Sandoz also continues to make strong progress on its other biosimilar clinical development programs which includes biosimilar versions of rituximab (Roche's Rituxan®/MabThera®) and adalimumab (AbbVie's Humira®).

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