Reuters: Regulatory News: Novartis tests copy of Amgen's Enbrel in late-stage trial

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Novartis tests copy of Amgen's Enbrel in late-stage trial Jun 24th 2013, 06:23 LONDON, June 24 | Mon Jun 24, 2013 2:23am EDT LONDON, June 24 (Reuters) - Sandoz, the generics unit of Novartis, has launched a late-stage trial with its biosimilar version of Amgen's Enbrel, consolidating its leading position in developing cheaper copies of complex biotech drugs. With the start of the major study of its version of Enbrel, or etanercept, Sandoz now has seven Phase III clinical trials across five biosimilar molecules - more than any other company in the industry. Sandoz said on Monday the new trial aimed to confirm the biosimilarity of its product versus Enbrel in patients with moderate to severe chronic plaque-type psoriasis. Results will be used to support U.S. and European regulatory filings. Unlike traditional chemical drugs, biotech medicines consist of proteins derived from living organisms that cannot be replicated exactly. Generic copies, therefore, are more difficult to develop and market. IMS Health, a provider of data for the healthcare industry, expects global spending on biosimilars to increase to between $4 billion and $6 billion by 2016, from just $693 million in 2011.

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