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By Stephen Pincock

THE ROUNDUP

Biosimilars: Europe Says Yes

EU regulators in April gave the green light to Europe's first "biosimilar" drug, the human growth hormone Omnitrope produced by Novartis subsidiary Sandoz. The drug is a generic for Pfizer's Genotropin and is expected to hit European markets shortly. Around the same time that Sandoz got its EU approval, a US federal judge ordered the Food & Drug Administration to rule on Sandoz's new drug application for Omnitrope, which the company had submitted in 2003.



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