European hormone ruling opens door to ‘bio-similar’ drugs

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Series Details 28.1.06
Publication Date 28/01/2006
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The European Medicines Agency on 27 January 2006 gave its first positive opinion for a similar biological medicinal product. The growth hormone Omnitrope, made by Sandoz, has been shown in studies to be of similar quality and efficacy to Genotropin, the original version of the drug, made by Pfizer. The ruling could bring about a raft of cheap biotechnology medicines and a new market for the drug companies able to produce them.

The final approval for Omnitrope must be given by the European Commission.

Related Links
European Medicines Agency: Press Release, 27.1.06: European Medicines Agency adopts first positive opinion for a similar biological medicinal product http://www.emea.europa.eu/pdfs/human/press/pr/3179706en.pdf

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