The FDA considers a wide range of products to be biologics. Products such as vaccines, blood and blood components, allergenics, somatic cells, gene therapy, tissues, and recombinant therapeutic proteins are all considered biologics by the FDA. These can be composed of sugars, proteins, or nucleic acids or complex combinations of these substances and can even be living entities such as cells and tissues. At the forefront are gene-based and cellular biologics used for biomedical research and may be used to treat a variety of medical conditions for which no other treatments are available.

 

Biologics differ from conventional drugs whose structure is generally known, whereas biologics are complex mixtures that are not easily characterized or identified. Biological products may offer new and effective means to treat a variety of medical conditions and illnesses that currently have no other treatments available.

 

To market a biological product the sponsor (generally the manufacturer) must have the biological product licensed via a biologics license application (BLA) under Section 351 of the Public Health Service Act (PHS Act). Following initial laboratory and animal testing that show that investigational use in humans is reasonably safe, biological products can be studied in clinical trials in humans under and investigational new drug application (IND) in accordance with the regulations at 21 CFR 312. The data from the studies must demonstrate that the product is safe and effective for its intended use in order to be submitted as part of a premarket application. FDA form 356h is used for a BLA submission.

 

The regulations regarding BLAs for therapeutic biological products include 21 CFR parts 600, 601, and 610. A biologics license is issued if it is determined that the product, the manufacturing process, and the manufacturing facilities meet applicable requirements to ensure the continued safety, purity, and potency of the product. If approved, FDA will issue a biologics license as part of the approval letter. Including in the letter is the US license number which must appear on all product labeling.

 

Folio Consulting Group, LLC has experience helping Biologics manufacturers successfully complete BLAs and gain licensure to access the US market. Contact us today to help develop your regulatory strategy and file your BLA.