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.

Biologics license applications (BLA) process (CBER) (FDA, 2021)

2020 Biological approvals (FDA, 2020)

What are the regulatory differences between an NDA and BLA? (Nuventra Pharmasciences, 2020)