Sandoz launches Phase III clinical trial for biosimilar etanercept

Holzkirchen, Germany, June 24, 2013 - Sandoz, the global leader in biosimilars, announced it 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 has a strong track record in developing and commercializing biosimilars around the world," said Ameet Mallik, Head of Biopharmaceuticals and Oncology Injectables at Sandoz. "We will leverage this experience and our industry-leading capabilities to bring a biosimilar version of etanercept to patients and physicians around the world." Etanercept is a tumor necrosis factor alpha (TNFa) inhibitor produced using recombinant DNA technology, and is approved in the U.S. and EU for the treatment of rheumatoid arthritis, psoriasis, and other conditions. Sandoz has invested significant resources in state-of-the art analytical technologies to develop and validate a process for producing its biosimilar etanercept. The company is also making the necessary manufacturing investments to bring this complex biologic to market.