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High quality biosimilars manufacturers like Sandoz must prove to regulatory agencies such as the FDA that its biosimilar products are highly similar to the originator reference biopharmaceutical to assure the equivalent effect in patients.

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As of last year, the biosimilar was in Phase II trials in Argentina, Austria, Brazil, France, Germany, India, Italy, Spain, and Turkey.

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Existing EU evidence is still limited and results show no clear pattern of market dynamics, although it is likely that biosimilars will result in smaller price reductions and lower market share than conventional generics.

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European one, is still being defined How many biosimilars has Sandoz already on the market?

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HOLZKIRCHEN, Germany, February 13, 2009 - Sandoz has received final approval for its third biosimilar, filgrastim, paving the way for this important oncology medicine to be made available to patients across the European Union.

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