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SANDOZ ACHIEVES IMPORTANT MILESTONES ON PHASE III TRIALS FOR KEY BIOSIMILARS PROGRAMS

April 28, 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 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 is currently preparing to file Filgrastim in the US and pegfilgrastim in the US and EU.

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®).

Sandoz is the global leader and pioneer in developing, manufacturing and commercializing biosimilars. Sandoz markets three biosimilar products, each of which are #1 in their respective categories globally and has over 50 percent market segment share of all biosimilars approved in the highly regulated markets of U.S., Canada, Europe, Japan and Australia. Sandoz' biosimilars are collectively sold in over 60 countries and have generated over 200 million patient exposure days of experience.

Click here to read about our Biosimilars pipeline.