Biologics License Application (BLA)
A biologics license application is the submission under which FDA licenses a biological product, requiring evidence that it is safe, pure and potent and that the manufacturing facility itself is fit.
A BLA is filed under section 351(a) of the Public Health Service Act and asks for a licence rather than an approval. The statutory standard is that the product be safe, pure and potent, and the licence attaches to the product and the facility together. The process is part of what is licensed, which is why a manufacturing change can require its own supplement and why a biologic cannot be reconstructed from its label.
For peptide readers the relevant licences are largely the ones that arrived by transition. On 23 March 2020 insulins, human growth hormone, glucagon, pancrelipase, chorionic gonadotropin, menotropins and hyaluronidase moved from new drug applications to deemed licences, which opened those molecules to the biosimilar pathway rather than the generic one. Reference product exclusivity runs twelve years from first licensure, with no biosimilar application accepted during the first four.
The practical difference from an NDA is the weight placed on process and on immunogenicity. Structural characterisation cannot fully define a large glycosylated protein, so comparability exercises, potency bioassays and anti-drug antibody data carry evidentiary load that chromatographic purity and mass spectrometry would carry for a synthetic peptide on the drug side.
The confusion worth clearing is that biologic does not mean made in a living system. Since the 2020 rule the category is set by size and type, not by manufacture, so a chemically synthesised polypeptide longer than 40 residues is a biologic and a recombinantly expressed 31-residue peptide is not. Sponsors do not select the pathway; the definition assigns it to them.