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Biologics’ Big Bang: Novel BLAs Balance Breakthroughs And ‘Biobetters’

This article was originally published in Pharmaceutical Approvals Monthly

Executive Summary

Both FDA’s biologics and drug centers posted historic BLA approval counts in 2014, combining to clear 21 novel biologics. The class is split between medical breakthroughs and “biobetters” offering incremental improvements, illustrating the maturation of the biotech industry.

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