Insulin, a hormone produced by the pancreas, plays a central role in regulating blood sugar levels. It facilitates glucose absorption from the bloodstream into cells. For individuals living with diabetes, whether Type 1 (body cannot produce insulin) or Type 2 (body does not use insulin effectively), synthetic insulin serves as a life-sustaining treatment. The discovery of insulin in 1921 marked a major medical breakthrough, transforming diabetes from a rapidly fatal condition into a manageable one.
Understanding Biologics
Biologics are a distinct class of medications derived from living organisms, such as cells, tissues, proteins, or genes. Unlike conventional small-molecule drugs that are chemically synthesized and have a simple structure, biologics possess large, complex molecular structures. These complex molecules are produced within living cells or microorganisms using advanced biotechnological processes. Examples of biologics include vaccines, blood products, gene therapies, and monoclonal antibodies, used to treat a wide array of conditions. Their intricate nature means they are generally harder and more expensive to produce than small-molecule drugs.
Insulin’s Classification
Insulin is classified as a biologic medication due to its nature as a large, complex protein molecule produced using living systems or biotechnology. In March 2020, all insulins on the market were officially moved under the biologic regulatory framework by the FDA. This means insulin is now regulated under the Public Health Service Act, similar to other biologics, rather than solely under the Federal Food, Drug, and Cosmetic Act for small-molecule drugs. This reclassification acknowledges that modern recombinant human insulin fits the definition of a complex product of living organisms.
How Insulin is Made
Modern insulin production primarily relies on recombinant DNA technology, a sophisticated genetic engineering method. This process involves isolating the human gene for insulin and inserting it into a bacterial plasmid. Bacteria, often E. coli or yeast, are transformed by introducing these recombinant plasmids. These genetically engineered microorganisms are then grown in large fermentation tanks, where they replicate and produce significant quantities of human insulin protein. The insulin is subsequently harvested, purified, and packaged for medical use.
Why the Classification Matters
The classification of insulin as a biologic has significant implications for its regulation, manufacturing, and accessibility. Biologic drugs follow a distinct regulatory pathway compared to small-molecule drugs, often involving more rigorous testing due to their complexity and potential for variability. Manufacturing biologics is inherently more complex, requiring stringent controls to ensure consistency and quality, as even minor changes in the process can affect the final product. Furthermore, instead of generic versions, biologics have “biosimilars,” which are highly similar but not identical copies of an approved biologic. The development and approval of biosimilars are complex, impacting their cost and availability, though they aim to offer more affordable alternatives to originator biologics.