What are biologicals?

By 2020, it is expected that 27 of the 50 most popular medical products are biologicals. If you use biologicals you naturally want to know what they are and how they work.

Since the turn of the century we have seen more and more biologicals on the market. This trend gives many people new opportunities to treat their disease. To fight a disease, medicines must bind to certain places in the body. Biologicals are able to bind to specific places in the body, that traditional medicines can’t reach. This gives thousands of people in the Netherlands new opportunities to reduce the symptoms of their illness.

What are biologicals

Biologicals are medicines made from “organisms” such as plants, animals or bacteria. The active substance is made from living cells, hence the name biological medicines or biologicals.

Most biologicals are large, complex structures. These structures are made up of different atoms that each contain a certain element. For example, the structure of water is made up of two hydrogen atoms (H) and an oxygen atom (O). Therefore, water can also be written as H2O.

Classic drugs, such as an aspirin consisting of 21 atoms, are a lot smaller than biologicals. A biological like Enbrel, used against Rheumatoid Arthritis, consists of 7054 atoms. Because of the many atoms, a biological is more difficult to make than a traditional medicine. Advanced methods and techniques are needed to make a biological. This means that making a biological is more expensive than traditional medicine.

Because biologicals are so large and complex, they become a lot more sensitive and fragile. This means that they can lose their effect more easily. By keeping the medicines in liquid form and between 2-8 degrees, it remains more stable. This is one of the reasons that biologicals must be injected and kept in the refrigerator. Many people would like to have their biological in pill form, but unfortunately this is not (yet) possible. Due to the sensitivity of the drug, it could not survive our gastrointestinal tract. In addition, the drug works faster when it is injected, because it is immediately present in the blood.

Why are biologicals so popular?

In addition to the expectation that 27 of the 50 bestsellers in 2020 will be biologicals, there is also the expectation that a quarter of the entire pharmaceutical market will consist out of biologicals. The reason for the popularity is the potential to bind to specific places in the body. To treat a disease, the medicine must bind to a receptor. A receptor is a protein that can be found on the outside of a body cell. A signal is emitted after binding of the drug to the receptor. It can be seen as a key and a lock. Hereby, the medicine is the key, which binds to the receptor “the lock”.

The traditional medicines were not able to bind in these specific places, and did not fit in the lock. Therefore, it was not possible to fight the disease. Thanks to the biologicals, diseases can now be treated that otherwise could not be treated. This is because the biologicals are able to open the right “locks”.

Due to the complexity of the biologicals, they only work in the specific place where they are needed. In other places they cannot bind, so there are fewer side effects. However, biologicals can cause an allergic reaction. Just like traditional medicines, it takes a little trial and error to find which biologicals works best for you.

How does a biological work?

The working mechanism of biologicals is quite complex, but I try to keep it as simple as possible here. Most biologicals are used to inhibit inflammation. When the body suffers from inflammation, the immune system is disrupted and as a result confuses cells.

The immune system consists of different cells, the most famous being white blood cells; such as B cells and T cells. These cells have the task of cleaning up malignant and foreign cells. When the immune system is disrupted, they see their own benign cells as intruders and try to clear them up. This releases certain messenger proteins, which causes the immune cells and the proteins to become overactive. This leads to inflammation which is the cause of various inflammatory diseases like Rheumatoid Arthritis.

Biologicals are antibodies that bind to immune cells and the messenger proteins. The binding to these cells and proteins ensures that they become less active, which ultimately inhibits inflammation.

There are also biologicals that do not inhibit inflammation such as growth hormones and insulin. They fall under the biologicals because they also come from living organisms. These are medicines that you have to take if the body cannot make them. Or when the body makes too little of it to be effective.

Biologicals may be a bit expensive and sometimes it is annoying that they have to be cooled. But there is a reason we see them more often. For millions of people worldwide, they offer the best solution to fight their disease!

Steven Gijselman

Bio-pharmaceutical scientist



Drugbank: https://www.drugbank.ca/drugs/

U.S. Food & Drug Administration: Vaccines, Blood & Biologics: https://www.fda.gov/biologicsBloodVaccines/default.htm

Pharmaceutical Commerce: http://pharmaceuticalcommerce.com/special-report/the-2015-biopharma-cold-chain-landscape/