Biologics’ Big Bang: Novel BLAs Balance Breakthroughs And ‘Biobetters’
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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The latest drug development news and highlights from our FDA Performance Tracker.
More than twice that number of novel agent applications have user fee goals coming up in the second half of 2015, putting FDA in good position to maintain its streak of high annual NME counts.
As the era of the primary care blockbusters waned, pharma R&D shifted toward less price-sensitive specialty fields. Now successful specialty drug development is producing its own sort of follow-on agents, and payers are pushing back. Even oncology is not immune.