BACKGROUND
What are BIOLOGIC DRUGS?
Biologics are medicinal products made in living systems, and they may be human, animal, or bacterial in origin. They are composed of complex molecules and macromolecules and can be living cells or tissues. Recombinant DNA technology is often employed to produce biologics. While other drugs are manufactured in chemical processes and have a specific composition, the structure and components of biologic drugs can be hard to analyze and characterize. In addition, the living systems which are used to produce biologics tend to be susceptible to contamination and very sensitive to changes in environmental conditions such as temperature and pH. Even slight alterations to the manufacturing process can impact the properties of a product and its efficacy in the human body. Because biologics are also difficult to analyze, there is no way to be completely certain through lab tests that the altered manufacturing procedure produced something as safe and potent as before. Therefore, in order to guarantee the consistency, quality, and purity of a product, manufacturers have to establish hundreds of process controls to ensure that the manufacturing process remains unchanged.
What are the DIFFERENT TYPES of biologic drugs?
Biologic drugs include vaccines, hormones, blood and blood components, monoclonal antibodies, tissues, recombinant proteins, and etc. They are also used in cellular and gene therapies.
To learn more about some of the different types of biologics, click here.
What are BIOSIMILARS?
Biosimilars can be thought of as the “generic” brand of biologic drugs. They are developed after the period of exclusivity on the originating drug has ended. However, in contrast to generic chemical drugs which contain the same active ingredients as their brand name counterparts, biosimilars are almost guaranteed to be slightly different due to differences in manufacturing. Because the process of producing biologic drugs is so complex and biopharmaceutical companies develop their own patented procedures, it is impossible for other companies to make an exact copy of the original biologic. While not completely identical, biosimilars show no clinically significant differences with the original drug in structure, safety, and potency.
What are the ADVANTAGES and DOWNSIDES of biologics?
Biologic drugs offer promising, new ways of treating a variety of conditions, such as cancer, rheumatoid arthritis and Crohn’s disease. They have allowed us to treat conditions that conventional drugs could not and made other treatments more effective. Further development in this area is likely to lead to significant advancements in the medical field. However, biologic drugs are currently more costly than the usual chemical drugs. This makes them less accessible and more burdensome to some patients, who may not be able to afford such expensive treatment year after year. Biosimilars are more affordable versions of biologics. While they are similar to the original drug, slight differences in composition and purity can affect the way they work in the body and potentially put the users at risk for serious health problems. Extensive tests would need to be conducted to ensure that they are at least as safe and effective as the original biologic and do not cause any additional adverse side effects. Biologic drugs, as they come from living systems, could also trigger immune reactions and increase the risk of infection; those considering biologic drugs for any given condition need to talk to their doctors about potential side effects and other medication and conditions they have, as these may interfere with the way the biologic functions.
What is FUTURE of biological drugs?
Continued development in biologic drugs would open the door to new possible treatments for a variety of diseases and disorders. Biological drugs are becoming an important part of the pharmaceutical industry, and biopharmaceuticals have “the potential to reach up to 50% in the global market in the next few years” (Citation 60). With the biosimilar market on the rise and hundreds of biosimilars in development, biopharmaceutical manufacturers are under pressure to adopt and develop innovations that would keep production costs low while maintaining the quality of the product. However, better regulations would need to be established for the biosimilars so that it is possible to ensure its safety and efficacy and track its performance.