EU Regulators Approve Generic Growth Hormone Omnitrope
Filed in archive Drugs, Vaccines and Therapeutics on January 29, 2006
The European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) gave a positive opinion on the generic growth hormone Omnitrope, bringing the first so-called "biosimilar" drug one step closer to approval in Europe.
Omnitrope is a cheaper version of a branded drug intended for the treatment of growth disturbance and growth hormone Deficiency in children and adults. It is recombinant-DNA derived, and being a biosimilar is the first biosimilar to be given backing by the EU panel
Omnitrope is already approved in Australia, but in the US, its approval from the FDA is still pending, and due to the delay, Sandoz has filed a lawsuit in Sept 2005.
Read full story from Reuters.
Tags: biosimilar growth biotech hormone omnitrope growth+hormone generic+growth hormone+omnitrope
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