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How Big Pharma Can Play To Win In US Biosimilars

This article was originally published in Scrip

Executive Summary

Successful entry into the nascent US biosimilars market is fraught with unknowns, but an analysis by independent research service BioMedTracker concludes that aspiring big pharma would be well advised to partner early, ideally when the drug is in development outside the US, and to use the 351(k) abbreviated pathway to get the quickest regulatory approval.



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