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

Published: Tuesday, May 06, 2014
Last Updated: Tuesday, May 06, 2014
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Company is currently preparing to file Filgrastim in the US and pegfilgrastim in the US and EU.

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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