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Europe approves first ever biotech generic

Published on 30/01/06 at 02:01pm

Europe's medicines regulator has approved Sandoz's Omnitrope, the world's first generic equivalent or 'biosimilar' of an existing biotech drug.

Patents on the first generation of biotech drugs have either already expired or are nearing expiry, but technical, regulatory and legal obstacles have prevented generic companies from marketing their own copies of the complex drugs.

But the market for biosimilar drugs is potentially worth billions, and the persistence of Sandoz looks set to pay off.

Sandoz (a division of Novartis) has been trying to gain marketing approval for their biosimilar drug Omnitrope in Europe and the US since 2003, but have been thwarted by the scientific and legal uncertainties.

Omnitrope is a version of somatropin, a recombinant-DNA growth hormone for use in the treatment of growth hormone problems in children and adults. The drug is currently marketed by a number of companies in Europe, including Pfizer under the brand name Genotropin.

Until now, a generics company would have to put their version of the drug through clinical trials to prove its safety and efficacy, but new EU laws allow biosimilar products to be marketed with an abbreviated approval process.

The drug just needs final approval from the European Commission before it can be marketed as the first biosimilar product. Current branded treatments are expensive and Sandoz said Omnitrope would bring costs down.

Andreas Rummelt, chief executive of Sandoz, said: "Omnitrope will contribute to cost savings in the healthcare systems and we are confident that the European Commission will now grant marketing authorisation."

After a protracted delay in the US, Sandoz filed a lawsuit in September against the FDA, seeking to force the regulator to make a ruling on its application, with a court date expected shortly.

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