What Are Biologics?
I am finding there are innumerable questions about biologics in this community. The most common of which is: “What are they?” So, I thought I’d take some time here explaining what they are. So, what are biologics? Here’s what to know.
We shall start by defining drugs and working our way down from there.
What are drugs?
These are made from chemicals synthesized (made) in labs. They are the end results of mixing certain chemicals. This chemical is mixed with that chemical. Their exact chemical structures of these medicines are known, and they are relatively simple. These end products are made into pills to be swallowed like Singular, or solutions to be inhaled like albuterol. 1-4
These products are then studied on animals. They are then studied on humans. Some are eventually approved by the FDA. They are patented. They are introduced to the market. They are made available for doctors to prescribe for said diseases, in our case asthma. 1-3
What are biologics?
Their full name is “biological products.” 1, 4 There’s actually an old and a new definition.
- First Generation Biologics (Traditional Definition). They are not drugs synthesized in labs. Instead, they are products derived directly from either animals or humans. A good example of a biologic is blood. When you receive blood, you technically are receiving a biologic. Vaccines are biologics, as they are grown in chicken eggs. Insulin is a biologic, as it comes from pigs. Antibiotics and vitamins may also be considered biologics. The term biologic was first used in the late 19th century. It was basically created as a term by the government as a means of regulating the “biologics” industry. For instance, they wanted to make sure vaccines and blood products were both safe and effective for people. 2-4
- Second Generation Biologics (New Definition). In lieu of modern research, the definition of biologics has been fine-tuned. So, here’s our updated definition: “Biologics are proteins and/or derivatives thereof that modulate the immune system, downregulate the inflammatory response or support the tumor-specific defense.” 2 For all sakes and purposes, this is the definition we are most interested in today. For now on, when we refer to biologics, this is what we are referring to.
So, what does this mean?
Unlike drugs, biologics are large, complex molecules. Also unlike drugs, their components are not well understood. They are proteins made from genes. These proteins may be antibodies responsible for some immune system response. Many of them are secreted by immune cells. So, they “modulate” (control) a certain immune response. 4
They are taken directly from living organisms. A sterile technique must be used when this is done to make sure you’re only getting the molecules you want. In order to be used as medicines, they must be replicated. But, they only replicate inside living organisms. This is because they need other proteins made by cells to replicate. 3
So, they are placed in artificial environments in labs. These environments include living tissues from animals, bacteria, or yeast. These tissues must be kept alive. So, this involves maintaining a proper temperature and humidity. It involves feeding them with proper nutrition. 3
These tissues obviously are made of cells. And these cells create the proteins needed for biologics to replicate. 3
The tissues used may be from animals, bacteria, or yeast. It is in these environments that biologics replicate. They replicate until they are available in large enough quantities to be used as medicine. 3
But, unlike drugs, they cannot be turned into pills to be ingested or solutions to be inhaled. They must be stored in special solutions. So, this means they must be stored in small vials.
So, in this way, biologics are grown “in biology.” They are grown biologically. And this is why they are called biologics. This is compared with drugs, which are made “non-biologically.” 6 The technology here is called biotechnology. 3
What to make of this?
Biologics in this sense has only been around for the last 15-20 years. 4 So, there are only a few biologics that have been approved by the FDA to use on diseases like ours. In fact, at the present time, there are only four biologics approved for asthma: Xolair, Fesenra, Cinqair, and Nucala. They are approved for severe asthma, and only as adjuncts with traditional asthma medicine. Finding out if a biologic might benefit you begins by having a discussion with your asthma physician.
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