CBER New Biologic Tally Healthy In 2013, But For Innovation Look To 2014
Executive Summary
Coagulation factors dominated the biologics center’s approvals in 2013, a solid year with eight novel BLAs cleared. Innovation level of 2013 CBER approvals was unremarkable, but first quarter of 2014 holds potential for advances in hemophilia and allergy treatment.
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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.
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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