CBER’s 2012 Approval Count Is Average, But Its On-Time Review Performance Exceeded Expectations

FDA’s Center for Biologics Evaluation and Research approved six original BLAs in 2012, a solid if unspectacular showing. But some of the center’s most interesting approvals are products that do not appear on the original BLA count: quadrivalent flu vaccines (supplements to predecessor trivalent products) and hemapoietic cord blood cells (not included under the PDUFA umbrella).

As FDA’s biologics center closes in on a decade since responsibility for therapeutic biologics was transferred to CDER, CBER posted a solid, if undramatic, year for approvals in 2012, with six original BLA approvals under the PDUFA framework.

Six approvals puts the 2012 CBER novel biologic class at the mid-point of CBER BLA activity in recent years, which...