1 December 2016 - Biologics is an umbrella term for therapeutic agents at least partially derived from living organisms such as yeast, bacteria, plant, or animal cells. 

Typically, biologics are large, complex molecules and include vaccines, gene therapies, and cellular therapies, often made using recombinant DNA technology. Insulins, erythropoietin, and an increasing number of cancer drugs are in this class of therapies. In 2005, biologics accounted for 32% of the $9.5 billion Medicare Part B drug spending; by 2014, these products constituted 62% of the $18.5 billion total.

The US FDA and the EMA may approve biosimilar agents based on the “totality of the evidence” from preclinical (structural, functional, mechanism of action, and animal toxicity) and clinical (pharmacological, immunogenicity, and efficacy) end points. If approved as a biosimilar for 1 specific indication, a product might subsequently be approved for clinical use across multiple indications of the original drug by extrapolation and might foster market competition that could lower the costs of biological therapies.

Read JAMA Editorial