The Difference between Biologics and Traditional Drugs

A biologic is manufactured from a living cell, often plant or animal, to create a complex mixture of molecules. A traditional prescription drug is typically manufactured through chemical synthesis, which means that it is made by combining specific chemical ingredients.

A traditional prescription drug can be analyzed to determine all its various components. By contrast, it is difficult or even impossible to break down the components of a complex biologic. In fact, some of the components of a finished biologic may be unknown.

While a traditional drug manufacturer can change the manufacturing process extensively to produce an identical final product, the living cells used to produce biologics can be sensitive to very minor changes in the complex manufacturing process. Small differences in the process can significantly affect the nature of the finished biologic drug and the way it works in the body.

For a generic drug manufacturer to win approval of a generic version of a traditional prescription drug, the product must have the same active ingredient, strength, dosage form and route of administration as the original drug. This means that generic drugs are the exact same chemically as their brand name counterparts and they act the same way in the body.

Such a process is not possible with biologics. Biologics manufacturers must ensure that the manufacturing process remains the same over time by tightly controlling the source and nature of starting materials and consistently employing hundreds of process controls that guarantee predictable results. When a “biosimilar” is created it requires a new manufacturing process, beginning with new starting materials. As a result, it will produce a product that is different from and not therapeutically equivalent with that of the brand name biologic.

Because of the complex process of manufacturing biologics, the only way to establish whether there are differences that affect the safety and effectiveness of the biosimilars is to conduct clinical trials on each new product.