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Biogenerics Are Coming and They're Not the Generics We Know

Biotech and would-be biogenerics companies are battling to shape the future of generic biologics. The FDA, along with established biotech and drug companies, has opposed the concept of biogenerics, insisting the compounds are too complex to be reproducible in a reliable fashion. Challengers insist that the science is advanced enough to make such products feasible and are pumping significant time and money into bringing them to market.

by Wendy Diller

With the FDA leaderless for two years, any comments from the newly appointed commissioner will be closely scrutinized. Thus, when Mark McClellan, MD, PhD, briefly mentioned during his Senate confirmation...

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