Difference Between Biologics and Conventional Prescription Drugs

Category: Medications & Supplementation Published on Wednesday, 22 April 2015 Written by Yong Tsai, MD

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 are extremely expensive due to complexities inherent in researching and developing suitable manufacturing processes for this therapy. On average, it costs approximately $ 20.000 annually to treat one severe RA patient and $ 32,500 for one severe lupus 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 bio-similar is to conduct clinical trials on each new product. Moreover, some companies do an end-run around patent laws, avoiding competition by delaying generic alternatives to the marketplace. Recently, one company has developed bio-similar biologics for RA treatment. My research center will start to conduct this clinical trial soon. Hopefully, in the next 5-6 years, we will have affordable biologics available.

Today, our country is at a crossroads in health care. We face unprecedented debt and unsustainable healthcare expenses. Even biologics are quite effective in RA and some other autoimmune diseases. Due to the safety issue and cost, not all patients with RA, 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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