Can Human Growth Hormone Be Genericized?
Genentech solidified its grip on the $350 million US market for human growth hormone through aggressive marketing, creative value-added services, and savvy timing. But a crop of new competitors, waiting for FDA approval of their nearly identical versions of the drug, are likely to change the basis of competition and most importantly, make pricing an issue.
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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.