Welcome to the Brave New World of Medicine: Biologics

As the world’s population has just officially surpassed 8 billion, scientists and medical researchers are busy delving into the human genetic code to explore, experiment and create new medications that can modify to your genes. Specialists can design treatments that are unique to you and prevent disease before it occurs, or treat existing diseases. These “biologic” medications are targeted to specific genotypes or protein receptors.

What are Biologics? 

Biologic reference drugs (or “biologics” for short) are medications made from isolated cells from living organisms such as micro-organisms, plants, animals, and human beings. Biologics use a substance that is made from a living organism, or its products can be used in the prevention, diagnosis, or treatment of a variety of diseases, including cancers, arthritis, and inflammatory bowel diseases like Crohn’s. Examples of biologic drugs include antibodies, interleukins, and vaccines. During COVID, we have heard of a biologic called monoclonal antibodies being used for treatment because they target the spike protein in the COVID-19 virus. 

  1. What is the difference between a Biologic and a Brand or Generic drug?

Biologics are derived from proteins cells or parts of cells of living organisms, which enables them to work at the cellular level to combat disease. They are large molecules with an inherently heterogeneous structure that can contain hundreds of amino acids. Non-biologic drugs are derived from chemical combinations rather than cells. The process for creating a biologic compared to a chemical-based drug is much more complex and yields small quantities which is why biologics are more expensive. 

  1. Are there different types of biologics & how do they work?

Ulcerative colitis occurs when the body produces too much of a protein called TNF-alpha. That protein causes the immune system to over-react and attack healthy cells in the digestive tract causing the inflammation which is ulcerative colitis. Remicade blocks the TNF-alpha protein which allows the intestinal lining to heal. Ulcerative colitis occurs when the body produces too much of a protein called TNF-alpha. That protein causes the immune system to over-react and attack healthy cells in the digestive tract causing the inflammation which is ulcerative colitis. Remicade blocks the TNF-alpha protein which allows the intestinal lining to heal. There are four classes or types of Biologics. One is a class known as tumor necrosis factor (TNF-alpha blockers), another is Interleukin (IL) inhibitors, B-cells Inhibitors, and T-cells inhibitors. These medications are administered by injection. 

Biologics work by targeting a gene or a protein. They are produced with a process called Recombinant DNA which requires isolating the DNA from human cells and potentially modifying that DNA segment, inserting it into bacteria or a mammalian cell, and getting that organism or cell to express it. This is a complex process which includes; locating genes that code for proteins, cloning genes, reproducing the proteins associated with the genes, determining the role of the proteins in the disease process, and then developing a potential therapy.

For example, Remicade, which is used to treat ulcerative colitis, works like this:

Ulcerative colitis occurs when the body produces too much of a protein called TNF-alpha. That protein causes the immune system to over-react and attack healthy cells in the digestive tract causing the inflammation which is ulcerative colitis. Remicade blocks the TNF-alpha protein which allows the intestinal lining to heal. 

  1. Costs of five of the top biologics 
  • Remicade $5,000 – $16,000 per infusion, on average, every 12 weeks 
  • Humira (adalimumab) used to treat ulcerative colitis, several types of arthritis, spinal disease, and uveitis (an eye disease) $89,000 – $109,000 per year
  • Revlimid used to treat lymphoma and multiple myeloma – $23,317 for 28 capsules 
  • Enbrel used to treat psoriasis and rheumatoid arthritis – $85,000 per year
  • Herceptin, used to treat breast cancer and other cancers – $35-45,000 per year
  • Biologics in Canada

    Biologics are regulated in Canada through Health Canada and the Food and Drugs Act and Regulations. The Biologic and Radiopharmaceutical Drugs Directorate (BRDD) reviews and provides market authorization of all drug submissions for biologic drugs for human use. The Alliance for Safe Biologic Medicines in Canada is focused on promoting biologics’ healthy usage and education for patients and health care professionals. 

    An Issue for Benefits Managers 

    Physicians choose to prescribe and use biologic medications for specific patients with conditions and diseases that are best treated with these drugs. Some Canadian provinces however are legislating “Forced Switching” whereby the health care system will move patients from their physician-chosen biologic medicine onto a preferred government-chosen less expensive product, often a biosimilar. This practice has been banned in nearly every European country. Some Canadian physician groups and patient advocacy organizations have raised concerns about the practice in Canada. 

    For benefits managers, the issue of coverage of the four broad categories of medications now available – brand drugs, generic drugs, biosimilars, and biologics – is more challenging as new drugs are being developed all the time. 

    At Health Risk Services, we are keeping a close eye on the issues and opportunities surrounding the four types of pharmaceuticals in the prescription drug space. We help benefits managers create or revise benefits plans to provide the most cost-effective benefits with the best possible offerings for employees. 

    To schedule your Complimentary Consultation with Health Risk Services, please call 403-236-9430 OR email: info@healthrisk.ca

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