Pipelines turn to biotech

Biologics have established a high profile along the whole research pipeline, accounting for four out of ten preclinical candidates and one in four submissions for US marketing approval. Cancer candidates predominate, with those in infectious diseases and the central nervous system not far behind. Only one new biologic was approved in 2006: paroxysmal nocturnal hemoglobinuria treatment Soliris (eculizumab). The rest were all based around existing products—either new versions or new uses in supplemental indications. Last year, Enbrel was the first biotech drug to break $4 billion in sales.

Biotechnology candidates by phase

Pending BLA submissions

Blockbuster biotech approvals

Investigational biotech drugs by indication

Top-selling biologics

Box 1: Biotechnology candidates by phase

Source: BioPharm Insight. IND, investigational new drug application; NDA, new drug application; BLA, biologics license application.

Box 2: Pending BLA submissions

Source: Cowen and Company. BLA, biologics license application; sBLA, supplemental BLA; PDUFA, Prescription Drug User Fee Act.

Box 3: Blockbuster biotech approvals

Source: Cowen and Company.

Box 4: Investigational biotech drugs by indication

Source: BioPharm Insight.

Box 5: Top-selling biologics

Source: BioCentury.