Sandoz Achieves Important Milestones on Phase III Trials for Key Biosimilars Programs
News May 06, 2014
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®).
The cholesterol-lowering drugs called statins have demonstrated substantial benefits in reducing the risk of heart attacks and strokes caused by blood clots (ischemic strokes) in at-risk patients. Since statins are associated with a low risk of side effects, the benefits of taking them outweigh the risks, according to a scientific statement from the American Heart Association that reviewed multiple studies evaluating the safety and potential side effects of these drugs.READ MORE
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