Sunday, June 23, 2013

Biosimilar News - Sandoz initiates Phase 3 trial for biosimilar Etanercept (Enrbel)

Sandoz, has initiated a major Phase III clinical trial with its biosimilar version of etanercept (Amgen's Enbrel). The global clinical trial will seek 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. The global clinical program was developed in consultation with regulatory authorities in the U.S. and EU, and the results from this clinical trial are expected to support regulatory submissions in both the U.S. and EU.

Sandoz is the pioneer in biosimilars and the global market leader with over 50% share of all biosimilars approved in the highly regulated markets of U.S., Canada, Europe, Japan and Australia. All three Sandoz products occupy the #1 biosimilar position in their respective categories

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