The Biologics License Application (BLA) for Marketing Approval in the USA

To introduce a biological product into interstate commerce in the USA; the sponsor of the product must gain Food and Drug Administration (FDA) approval of a Biologics License Application (BLA). Biological products require manufacturing processes of greater complexity than those for small-molecule drugs; and control of the processes is critical to assurance of the products’ safety; purity and potency. This module describes the requirements that must be met to obtain licensure of a biological product. Subjects covered include the regulatory context; the content and format of the BLA submission; the review process; and provisions for expedited development and review.