Biologics license application (BLA)


A request to the US Food and Drug Administration (FDA) for permission to market a new biologic product.

Formally, a BLA is defined as a request for “permission to introduce, or deliver for introduction, a biologic product into interstate commerce in the US”. A BLA is broadly equivalent to a new drug application (NDA) for traditional small-molecule drugs. It should contain all the information needed to demonstrate the product’s safety, potency and purity.