BIOLOGICS- biologics are medications that are derived from organic matter, are made inside living organisms or their cells in contrast to chemically synthesized drugs. Insulin, antibodies, blood and blood products, tissue grafts, stem cells are a few examples of biologics.
The structure, source, manufacturing process and therefore regulatory requirement for biologics differ from traditional drugs. These medicines are difficult to produce as either the targeted protein or genetic material is extracted from the living cell or recombinant DNA technique is used to create a living cell which produces targeted product, which is further extracted by cloning the cells and purifying the product. This is quite a complex process and needs strict regulatory checks to ensure the quality and potency of therapeutic products.
In order to meet these standards a manufacturer has to apply for BLA- Biologics Licensing Application after completing the clinical studies. BLA can be considered as a counterpart of NDA (New Drug Application) which is necessary for synthetic drugs. The submission of BLA is made by submitting the Form FDA 356h generally to CBER (Center for Biologics Evaluation and Research) and rarely to CDER (Center for Drug Evaluation and Research).
The BLA contains extensive details of- manufacturing process, non- clinical data, clinical data and labeling information, to meet safety, quality and efficacy standards. The application is thoroughly reviewed by the FDA teams with help from wide variety of subject matter experts; the process may take upto 10 months and when the authorities provide the approval the manufacturer may introduce the product in market and start with the post marketing surveillance to check real world effectiveness of medication.
Biologics provide a hopefull future in treatment of complex disease like autoimmune diseases and cancer.
However there are major concerns regarding their use, are you aware of any of those?
MBH/PS
It’s great to see how biologics - like antibodies, vaccines, and stem-cell-based therapies - differ from traditional drugs and why they require a dedicated regulatory pathway. Your explanation makes it easy to understand how the BLA ensures these complex therapies meet rigorous safety, quality, and efficacy standards before they reach patients. 
