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

A traditional 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.  The biologics can be very 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.  Each step of the manufacturing process must be carefully developed and monitored, and the final product quality controlled and verified in clinical trials.

Biologics such as monoclonal antibodies, cytokines and others have been used to treat many areas of medicine.  Biologics, such as Enbrel and Humira, are extremely expensive due to complexities inherent in researching and developing suitable manufacturing processes for this therapy.  On average, it costs approximately $14,000 annually to treat one severe rheumatoid arthritis (RA) patient, $32,500 for one lupus patient, $27,000 for one Wegener’s granulomatosis patient.  Even factoring in the cost of research and development of biologic drugs, these costly medications provide pharmaceutical companies a financial windfall.

For a generic drug manufacturer to win approval of a generic version of a conventional 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.  Repeated clinical trial is not required.  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 biosimilar is to conduct clinical trials on each new product.  In the past few years, some companies have developed bio-similar biologics which are relatively cheaper than original but are still very expensive.  Therefore, it is unlikely, in the foresee future, we will have an affordable biologics available.

Today, our country is at a crossroads in health care.  We face unprecedented debt and unsustainable healthcare expenses.  Biologics are quite effective in rheumatoid arthritis, psoriatic arthritis and some other autoimmune diseases.  However, due to the safety issue and cost, not all patients with rheumatoid arthritis, psoriatic arthritis or other autoimmune diseases need to be treated with biologics.  Most patients can be treated effectively with conventional drugs, if treated earlier and properly.  Biologics should be used in a highly selective way for patients who would benefit from biologic treatment.

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