Will Biologics be the Main Drugs of the Future?

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Table of Contents

Introduction
Types of Biologics
Modern Day Usage of Biologics
Benefits of Biologics
Drawbacks of Biologics
Conclusion
Reference List

Introduction

Chronic illnesses such as rheumatoid arthritis and crohn’s disease are mainly caused by immune systems that tend to overreact. Apparently, the overreaction causes carrier substances that alert the body about infections to be generated in large quantities (Boehncke & Radeke 2007). Consequently, this is usually countered by setting up a very strong immune system in a patient’s body. In the process, various tissues that are found in the body are severely attacked and ruined. For normalcy to be realized, specific reagents are required to trigger the immune system to action. Possibly, this is where biologics comes in. According to Boehncke and Radeke (2007, p. 1), biologics are generally regarded as proteins that are responsible for modulating a body’s immune system. Biologic drugs also help to regulate inflammatory responses downwards. Despite being considered as a modern day idea, biotechnology has been in existence for ages. Unlike in the olden days, however, biotechnology currently affects every aspect of our lives. In generally, the uniqueness of biotechnology drugs or biologics as they are commonly referred to has to do with the fact that biologics help to improve the state of a patient’s body through a natural process. To date, biotechnology has been utilized to create numerous drugs for dealing with different clinical conditions. Apparently, hundreds of medical conditions can be treated using biotechnology drugs. Among the illnesses that can be treated using biologic drugs are cancer, autoimmune disorders, and hepatitis C.

As opposed to drugs that are synthesized through a chemical process, biologic drugs are obtained from living sources such as animals and human beings (Wood & Foote 2008). In a definition given by the US Code of Federal Regulations, a biologic product refers to any virus or toxin used in the prevention or treatment of illnesses that attack human beings. Drawing from a study by Mulberg, Murphy, Dunne and Mathis (2013, p. 313), there has been a significant increase in the number of biologic products over the years. Considering that nearly 40 percent of pharmaceutical products are presently based on biologics, there is a rising concern among stakeholders concerning the effectiveness of biologic drugs. A key concern is whether the use of biologic drugs will dominate the future of the pharmaceutical industry.

It is thus imperative to understand what the growth and development of biologics means for the future. This paper explores a number of issues related to the use of biologics and makes an attempt to answer this question. Specifically, the paper looks at various types of biologics, benefits and drawbacks of biologics, and contemporary usage of biologic drugs. Toward the end, the future of biologics in the pharmaceutical industry is discussed.

Types of Biologics

Since inception, different types of biologic therapies have been developed and can be used to treat different clinical conditions. To date, US Food and Drug Administration has granted approval to many forms of biologic therapy. However, there are some forms of biologic therapy that are reserved for experiments that involve the participation of cancer patients in clinical trials. According to Vachani and Millar (2010, p. 1), types of biologics include colony stimulating factors, monoclonal antibodies, vaccines, interleukin, interferon, and gene therapy. For ease of understanding, these types of biologic therapies are usually placed in different categories including drugs, vaccines, advanced therapies, and traditional vaccines also referred to as blood products or vaccines. The drugs category is made up of monochlonal antibodies, recombinant proteins, recombinant or synthetic peptides, and antisense. Monochlonal antibodies are antibodies that hold specific antigens normally expressed by cancer cells. The vaccines category is made up of recombinant and DNA vaccines while advanced therapies consists of gene therapies, cell therapies and tissue engineered products. The same cells are later transformed and fed back into a patient’s body. For safety reasons, vaccines must go through an elaborate review process in a well protected and safe laboratory environment. The review process also helps to guarantee the effectiveness and purity of the vaccines.

Modern Day Usage of Biologics

As pointed out earlier, biotechnology has been in existence for many years. Unlike in the olden days, however, the use of biologic therapies currently affects every aspect of our lives. In general, the uniqueness of biotechnology drugs or biologics as they are commonly referred to has to do with the fact that biologics help to improve the state of a patient’s body through a natural process. To date, biotechnology has been utilized to create numerous drugs for dealing with different clinical conditions. Apparently, hundreds of medical conditions can be treated using biologic drugs. The illnesses that can be treated using this technology include cancer and autoimmune disorders among others. In order to guarantee the safety of patients, it is advisable to develop standards and guidelines that should form the basis of all activities that have to do with the advancement of biologic drugs. This also helps to promote effectiveness and seriousness in the pharmaceutical sector.

In the recent past, the use of biologics to treat rheumatoid arthritis has been on the increase. Based on research findings, rheumatoid arthritis is a chronic ailment that affects scores of people across the United States. The disease subjects patients to pain, stiffness and swelling. It is mainly responsible for the destruction of bones and joints in the body. Debatably, lack of expert treatment for rheumatoid arthritis can have very severe outcomes. Joints may be destroyed permanently and victims may have their bones deformed. It is thus advisable to ensure that the condition is treated as soon as possible to avoid serious repercussions. In general, the overall condition of a patient is seriously affected by rheumatoid arthritis. Usually, individuals suffering from this condition are unable to work and often die prematurely. Obviously, this has a major effect on the overall development of a nation. As a result of improved research activities, clinical experts now have a better understanding of rheumatoid arthritis. The knowledge acquired by stakeholders regarding rheumatoid arthritis has been utilized to come up with a number of biologic treatments for the illness. By targeting specific cells and cellular interactions it has been possible to develop biologic therapies for dealing with rheumatoid arthritis. Ostensibly, biologic therapies have been approved by the US Food and Drug Administration as a solution to a number of clinical conditions including rheumatoid arthritis. Although they can be used in isolation, biologic drugs are sometimes combined with other drugs for better outcomes.

By and large, biologic therapy presents clinical experts with a new way of dealing with rheumatoid arthritis. Considering that scores of people have been affected by the illness, the need for an effective control system can not be underscored. Among others, patients who suffer from rheumatoid arthritis experience continual pain in the joints. Together, joint pains, swellings, and stiffness that are felt by victims of rheumatoid arthritis end up destroying the bones. In the absence of proper medical care, patients may suffer permanent bone damage or deformation. Among the common symptoms of rheumatoid arthritis are anemia and tiredness. In some severe cases, patients may end up with serious medical conditions. Generally, the quality of a patient’s life deteriorates drastically. Despite the fact that rheumatoid arthritis does not have an existing cure, it is possible to save a patient’s life through the use of biologic therapies. Apparently, the development of biologics treatment has been of great benefit to the medical fraternity as far as the control of rheumatoid arthritis is concerned. Typically, biologic therapy agents are made in such away that they can help to lower signs and symptoms of rheumatoid arthritis in affected individuals. Among others, this is very vital for hindering the progress of the illness and promoting quick patient recovery. The first biologic drug used for treating rheumatoid arthritis is referred to as tumor necrosis factor (TNF) and has been approved by the US Food and Drug Administration. Apparently, this was followed by the subsequent production of many other biologic agents.

Despite the fact that the cause or causes of rheumatoid arthritis are not very well understood, it is imperative for health care experts to keep improving their understanding of biologic therapies in order to offer excellent care for patients with rheumatoid arthritis. In terms of efficiency, biologic agents are highly effective and present health care professionals with an excellent solution to treat rheumatoid arthritis. Biologics help to reduce the advancement of rheumatoid arthritis, make the quality of life better, and improve an individual’s physical well being. Evidently, patients tend to respond to treatment faster and results may be realized within a very short period. The efficiency of the drugs is checked frequently in order to ensure great outcomes. Arguably, the approach has made it possible for clinical experts to realize to take good care of their patients. Although biologic therapies provide an efficient solution for treating patients with rheumatoid arthritis, it is costly and places a heavy financial burden on clinical systems as well as on patients. The overall cost of treatment is thus the greatest challenge associated with the use of biologic therapies. This notwithstanding, the life of a patient is important and regardless of the cost involved, it is imperative to do everything possible to help a patient. Ostensibly, the high cost of biologic therapies can be explained by the fact that in the long run, the cost of caring for a patient with rheumatoid arthritis is higher than administering a biological treatment to the affected individuals. In treating patients using biologic agents, the choice of treatment may be affected by factors such as preferences by patients and physicians.

Biologic therapy can also be used when providing clinical care for patients with cancer. Apparently, the body’s immune system has an important part to play in the treatment of cancer using biologic drugs. In general, the body’s immune system is made up of a multifaceted connection of different body organs and cells. Apparently, the immune system identifies and fights any foreign substances that threaten the survival of an affected patient. In most cases, the foreign substances that invade the body include bacteria and viruses. Other foreign substances include abnormal cells that may be found inside the body. Usually, an immune response is activated immediately a foreign substance is detected in the body. To a large extent, the body’s immune system is controlled by white blood cells. In order to keep the body safe, a number of these cells are responsible for protecting the body against any form of invasion by strange bodies. Some white blood cells are developed to deal with specific targets in the body. For individuals affected by cancer, it is alleged that biologic therapy may be used to help them in two ways. It is either used to provide cancer treatment directly or to reduce the negative effects that are created by other forms of cancer treatment. As has been explained, the body’s immune system plays a very important role in detecting and destroying abnormal cells in the body so as to prevent cancer. Unfortunately, cancer cells have the ability to escape detection using various tactics. One of the strategies used by cancer cells to evade detection is to undergo genetic transformation that causes them to be invisible to detection mechanisms used by the immune system. During cancer treatment, biologic therapies are used to strengthen various components of the immune system. They may also be used to counter the effect of suppressive signals usually generated by cancerous cells.

Although not very well developed, the use of biologics is slowly taking shape in orthopaedics. Other than relying on surgery techniques, platelet-rich-plasma, stem cells, and bone marrow aspirate are biologic solutions that can now be used by orthopaedic surgeons to treat their patients. Biologics are thus bound to play an important role in orthopaedics just like in any other medical area. Going forward, the use of biologic therapies will continue to revolutionize how things are done by orthopaedic surgeons. In sports, for example, it is presumed that biologics will remain central to the treatment of conditions such as rotator cuff and cartilage industries. In various ways, biologic therapies will help to speed the healing of bones and wounds in affected individuals. While platelet-rich-plasma can be used to enhance healing after a tendon has been torn, stem cells have unique capabilities that help to repair body tissues and speed up recovery from injuries. However, as pointed out earlier, research activities are still going on to understand how biologics can be used successfully. Orthopaedic surgeons should thus continue using the current technology while waiting future developments.

According to Vachani and Millar (2010, p. 1), it is possible for cancer patients to tell whether their bodies are responding positively to biologic therapies. Seemingly, it is the type of cancer that determines how a patient responds to biologic treatment. Ostensibly, there are various technologies that make it possible for patients to check how they are responding to treatment. It is imperative to carry out this exercise periodically in order to check how cancer tumors are responding to biologic treatments. In most cases, the measurement of the tumor is conducted through a blood test. The effectiveness of the biologic therapy is indicated by a reduction in the size of the tumor. A decline in the symptoms exhibited by a patient also indicates that the biologic treatment is working as desired. Where a patient is unable to carry out the measurement, he or she can seek help from doctors or nurses. Ostensibly, some biologic therapies tend to have a negative effect on some molecules that support the development of tumors. These biologic treatments are scientifically referred to as targeted cancer therapies.

In using biologic therapies, it is important to follow guidelines that are set by organizations charged with doing so. In the United Kingdom, for example, the National Institute for Health and Clinical Excellence came up with guidelines to ensure that biologic therapies are administered in the most appropriate way. In general, following such guidelines ensures that every practitioner follows a standard way of doing things. It helps to eliminate room for individuals coming up with their own styles and ensures that the quality offered to all patients is the same across board. Efforts must thus be made to develop such standards so as to remove any form of confusion and create orderliness in the pharmaceutical industry.

Benefits of Biologics

Biologics or therapeutic proteins have been very useful to the medical industry and their usefulness is bound to continue into the future (Pickering 2007, p. 1). Seemingly, this is because researchers are working round the clock to improve the performance and use of biologics. One of the greatest benefits of biologic drugs has to do with the fact that they have fewer side effects. The use of biologics or therapeutic proteins is also helpful for dealing with serious medical conditions and makes it possible for health care providers to offer highly specialized and improved treatment for different medical conditions.

Unlike other forms of therapy, biologics makes it possible for the body’s immune system to operate efficiently by using substances that are generated by the body through a natural process. Although biologic drugs generally cause the human body to produce more of the natural substances, these substances may also be made by the body when need arises. There are other types of therapies that make use of cells inside body. Unlike small molecule drugs, biologic drugs do not have to be injected into the body. Given that this is the greatest source of side effects, the risk is somehow lessened if not completely eliminated. Effects associated with drugs that have to be injected include skin reactions that mostly affect patients around the injected areas. The fact that biologic drugs subject patients to fewer side effects is thus a great advantage for both the patients and health care experts.

As opposed to the action by the chemotherapy, biologic therapy collaborates with the body’s immune system to counter the effect of cancer on a patient. While a patient’s immune system generally assists with the prevention of illnesses, it is very central in stopping the spread of cancer in the body. Arguably, biologic therapy is meant to strengthen the body’s natural immunity against cancer attack. Despite the fact that it is not very clear to doctors how biologic therapy manages to deal with these attacks, it is obvious that biologic treatments play a vital role in hindering the spread of cancer cells in the body. By slowing down the spread of cancer cells, the body is able to use its internal protective mechanism to get rid of the dangerous cells. In addition, cancer is prevented from spreading to other areas of a patient’s body. As pointed out by Vachani and Millar (2010, p. 1), there are some biologics that are used to counter the side effects of other types of treatments administered to a patient. Specifically, there are some that help with the production of important body cells immediately after a treatment session. Arguably, this is very helpful in lowering the risk associated with neutropenia and the subsequent reduction of infections. The use of biologic treatments also assists the body to generate red blood cells.

Drawbacks of Biologics

Although biologics tend to have fewer side effects on humans, one disadvantage associated with their usage is that they have to be injected (Lappin 2013, p. 1). Arguably, this reduces the effectiveness the drug. Furthermore, injection increases the risk of a person being infected. Research findings point to the existence of several cases of infection as a result of patients being injected with biologic drugs. Apparently, this does not happen where patients are injected with small molecule drugs. This notwithstanding, it is alleged that the future of biologics or therapeutic proteins is quite bright and their use is bound to continue rising with time. Although the effects of biologic therapies vary according to the type of treatment administered, the reactions are generally the same.

As has already been explained, some biologic therapies make use of the naturally occurring substances in the body. In spite of this, there are possibilities of side effects due to over production of the natural substances or administration of higher doses (Vachani & Millar 2010). Ostensibly, the side effects associated with biologic therapies are caused by the invigoration of the body’s immune system. Notable side effects include body aches, nausea and vomiting, poor appetite, fever, chills, and fatigue. Based on how the biologic therapy is carried out, a patient may experience various clinical complications. Research findings, however, indicate that side effects diminish several hours after treatment (Vachani & Millar 2010). Considering that the field of biologic therapies is still growing, research professionals are yet to determine the exact long term effects associated with the use of biologic drugs.

Research about the use of biologic therapies has also been hindered by the fact that the testing of most biologics among commonly used animal species including rats and dogs is generally not easy. Consequently, research professionals are compelled to utilize a variety of tests in order to obtain the intended outcomes. In addition, most biologics bring forth immune responses that can easily interfere with preclinical results. Although such interferences may be desired in some cases, unwanted immunogenicity might have harmful results that could harm a patient. Some of the undesirable effects include extending the biologics activity or the creation of immune complexes. For this reason, it is imperative for research experts in the clinical sector to obtain the samples required for carrying out clinical tests. Moreover, the effects of the formation of antibodies on pharmacokinetics (PK) and pharmacodynamics (PD) as well as associated adverse effects should be taken into account. Unless it is determined that the immune response will greatly neutralize the effects of biologics, the detection of antibodies should not lead to the termination of a preclinical study.

Unlike the use of traditional treatment options, biologic therapies utilize very expensive drugs and are thus quite costly. In most cases, the massive costs associated with the use of biologic therapies are offset by the reduced number of hospital visits and admissions. Because of their complex nature and how they are manufactured, biologic drugs are extremely sensitive to the environment. Other than the complex nature of biologics, environmental sensitivity of biologics is also as a result of the chosen mode of action. In order to caution health care providers and patients against the high cost associated with biologic therapies, it is advisable for state governments to consider having a state funded insurance system that caters for all individuals. The insurance system should be able to cover all patients and health care professionals equally. By so doing, the financial burden on patients and health care providers will be lessened and the use of biologic drugs will receive overwhelming support from the public. Consequently, the field of biotechnology drugs will continue to advance powerfully.

Are Biologics the Future of Pharmaceutical Drugs?

The increased use of biologic drugs has created a new concern in the medical sector and stakeholders are now wondering whether biologics will form the bulk of drugs that will be used in the future. In a research carried out by Tufts University Center for the Study of Drug Development (TUCSDD), it became apparent that the use of biologic drugs is increasingly becoming popular in the contemporary world (Lappin 2013, p. 1). Consequently, the importance of biologics as a solution to clinical problems can not be overlooked. While biologic products accounted for a mere 7% of the total revenue by ten pharmaceutical firms in the United States in 2001, the percentage steadily increased to 71% in 2013. Arguably, biologics or therapeutic proteins may eventually get rid of small molecule drugs from the market.

Although there are several drawbacks associated with the use of biologic therapies as earlier explained in this paper, it is apparent that biologics are likely to form the bulk of future drugs. Undoubtedly, the benefits of biologic therapies outweigh the drawbacks and this implies that the use of these therapies will keep rising. Despite being expensive, biologic therapies provide a natural solution to most health challenges. As already explained illnesses that have successfully been treated with the help of biologics include rheumatic arthritis and cancer. To an extent, the primary focus of large pharmaceutical firms has now shifted from the development of small molecule drugs to promotion of biologic drugs.

By and large, biologic therapies are promising better results in the long run without major side effects. Because of the reduced number of side effects, recovery is usually faster. Besides, the number of additional treatments is also reduced. For patients, the use of biologic therapies is a welcome move since it helps to improve their lives in the long run. A total of eighteen biologic drugs have received the approval of FDA and are presently being used to treat rheumatoid arthritis and asthma among others. As earlier explained, biologic therapies also play an important role in the treatment of cancer. Although biologic drugs are quite expensive, it is presumed that the cost of production will reduce with time. As a result, the use of biologic therapies will become very popular and possibly displace small molecule drugs. To a large extent, the benefits associated with the use of biologic drugs have made their approval by FDA simpler and faster. Dependence on biologic drugs is bound to grow as people continue aging. As people advance in years beyond the teenage age, dependence on biologic drugs is bound to grow. As a consequence, the demand for health care services will equally increase.

Certainly, the development of biologic drugs is not about to stop. As a matter of fact, stakeholders are making every effort to devise improved methods of developing these drugs. As the development and use of biologic drugs continues to receive attention, it is presumed that the world will reach a level where biologic drugs will be used for all medical conditions. Consequently, these drugs will form a very strong foundation for the future of clinical medicine and treatment. Because of the explosive growth of biotechnology, research indicates that some pharmaceutical firms have slowly transformed their identities to promote the use of biologic drugs. Big Pharma, for example, opted to change its name to Big Biotech as a result of the growth in the use of biologic therapies.

Without neglecting the manufacture of small molecule drugs therefore, gigantic pharmaceutical firms across the world are heavily involved in the development and growth of biologic drugs. Clearly, this indicates their confidence in biologic therapies and points to the fact that biologics will dominate the pharmaceutical industry in the future. Although efforts are being made to integrate small molecule drugs and biologics, there is every reason to believe that biologics is the way to go as we move into the future. As with any other technological advancement players that fails to accommodate this new development may become irrelevant in the pharmaceutical sector. As pointed out earlier, the future of biologic drugs though bright, could be hindered by concerns about safety and prohibitive costs. Arguably, safety concerns associated with the use of biologics do not affect small molecule drugs. Immunogenicity is one of the safety concerns associated with biologics. It causes a patient’s antibodies to view drugs as viruses that must be dealt with accordingly. Consequently, the body is unable to respond positively to treatment. In order to effectively address the security concern, biologic drugs are required to undergo a thought licensing process. It is therefore important to check whether biologic products meet the required standard. The other factor that stakeholders must be concerned with is the high cost of developing biologic drugs and administering biologic therapies.

Conclusion

Inferring from the discussion presented in this paper, biologics will undoubtedly constitute the bulk of future drugs. With increased research efforts among scientists and scholars there is a very high possibility that the use of biologics will soon permeate every section of the medical sector. As discussed in this paper, there are several benefits that are associated with the use of biologic drugs. Unlike small molecule drugs, biologics make use of the body’s natural immune system to protect patients. In addition, biologic drugs do not have to be injected into the body. Given that this is the greatest source of side effects, this risk is somehow lessened. Effects associated with drugs that have to be injected include skin reactions that mostly affect patients around the injected areas. The fact that biologic drugs subject patients to fewer side effects is thus a great advantage for both patients and health care experts.

Although there are heavy costs involved when using biologic therapies to treat patients, the eventual cost of taking care of a patient is lower. Therefore, while the initial cost appears prohibiting, the cost is negligible when one factors in all other aspects of the treatment. Furthermore, so much time is lost in the process as one takes care of a patient with a terminal illness. It is necessary for state governments to protect health care providers and patients against the high costs associated with the use of biologic drugs. Governments should consider having an insurance system that can effectively cover patients without neglecting the nurses taking care of them. By so doing, the financial burden on patients and health care providers will be lessened and the use of biologic drugs will grow.

Without a doubt, lack of expert treatment for various medical situations can have serious outcomes. Depending on the type of illness, a patient may have breathing difficulties, experience pains in joints, or suffer deformed bones. In a worse case scenario, a patient may have his or her joints destroyed permanently. It is thus advisable to ensure that any condition detected is treated as soon as possible. By all means, delayed onset of treatment should be discouraged in order to save a patient’s life. Generally, the overall condition of a patient may seriously be affected. Usually, affected individuals are unable to work and often die prematurely. Unfortunately, this has a major effect on the economy of a country. As a result of improved research activities, clinical experts are now better equipped with knowledge on how to use biologic drugs to treat patients.

As we move into the future, there is every reason to believe that the use of biologic drugs will keep on increasing. Evidently, the number of clinical conditions that can be addressed with the help of biologic therapies has been on the rise over the years. Further efforts are being made by stakeholders to ensure that biologic drugs can be used to deal with almost every medical condition. For this reason, it is imperative for pharmaceutical firms to invest in the development of biologic drugs and get ready to face the future with confidence. As earlier explained, the onset of biologic therapy has greatly simplified the work of clinical experts. Considering that there are many people who have been affected by long term illnesses such as rheumatoid arthritis and cancer, the need for an effective control system can not be underscored.

Undoubtedly, the development of biologic drugs is not about to stop. As a matter of fact, stakeholders are making every effort to devise improved methods of developing biologic drugs. As the development and use of these drugs continues to receive attention throughout the world, it is assumed that most illnesses will be treated using biologic drugs. As a result, there is a very high possibility that biologic drugs will form a very strong foundation for the future of clinical medicine and treatment. Because of the explosive growth of biotechnology, research indicates that some pharmaceuticals firms have slowly transformed their identities in order to promote the use of biologic drugs. Big Pharma, for example, opted to change its name to Big Biotech for this reason.

Reference List

Boehncke, WH & Radeke, HH 2007, Biologics in General Medicine, Springer Science & Business Media, New York.

Lappin, G 2013, Are Biologics the Future?, Web.

Mulberg, AE, Murphy, D, Dunne, J, & Mathis, LL 2013, Pediatric Drug Development, John Wiley & Sons, Hoboken, NJ.

Pickering, L 2007, Are Biologics the Wave of the Future?, Web.

Vachani, C & Millar, LB 2010, Biologic Therapy: The Basics, Web.

Wood, LF & Foote, M 2008, Targeted Regulatory Writing Techniques: Clinical Documents for Drugs and Biologics, Springer Science & Business Media, New York.

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