What is biological treatment?(General explanation)

Biological drugs are medications whose active substance has been produced "biologically" in a living organism (yeast, bacteria). Conventional drugs are manufactured "chemically" through chemical synthesis processes.

Through biological processes, we can produce molecules thousands of times larger than through traditional chemical synthesis. The most commonly used drug in the world (paracetamol) consists of 20 atoms, while a biological drug can have up to 20,000 atoms (typical monoclonal antibody).

The most well-known biological drug is insulin – a hormone without which type 1 diabetics cannot survive.

Biologicals also include other hormones, vaccines, gene therapy, blood and its derivatives, therapeutic allergens, therapeutic peptides and proteins, fusion proteins, oncolytic therapeutic viruses, CAR T-cells, monoclonal antibodies, antibodies conjugated with drugs, and many others.

Most modern biological drugs are monoclonal antibodies. If your doctor intends to initiate a new therapy and tells you it is a biological treatment, it will likely be a certain type of monoclonal antibody.

They are naturally occurring protein molecules with the ability to selectively bind to structures (antigens) on the surface of a cell and thereby initiate an effect (send a signal), or conversely, not initiate any effect and simply block the site to prevent other molecules from binding there (block the signal).

• Monoclonal antibodies, therefore, bind to one specific antigen
• Polyclonal antibodies can bind to multiple antigens.
• There are also bispecific monoclonal antibodies capable of binding to precisely two different antigens.

You can recognize a monoclonal antibody by the name of the active substance, which ends in -mab. The nomenclature of monoclonal antibodies has its rules, which allow you to decode their therapeutic target as well as their origin (human, humanized, murine, etc.).

+ Advantages

One advantage of such large molecules is that they behave more selectively in the body. They bind where we want them to and do not affect anything else. In practice, this means that their efficacy is significantly higher than the efficacy of other types of treatment while causing fewer adverse effects.

Another advantage is that they are metabolized differently in the body compared to small molecules. Contradictions with other drugs are therefore less common, which is important, especially for people who are being treated for multiple conditions. Especially in older age, it is common for a person to take multiple tablets daily, and they can interact with each other.

Modern biological drugs are almost always administered by injection. The advantage is that they are usually administered once every few weeks, depending on the drug. Many biologics come in the form of an injection pen or a pre-filled injection, allowing for self-administration at home.

- Disadvantages

One disadvantage may be the method of injection, which can be unpleasant for some.

The availability of biological treatment is considered a disadvantage because with many conditions, patients must first undergo conventional treatment, and if it is ineffective or not tolerated, they can then transition to biological treatment after tests and lung examination.

Due to the high cost of biological treatment, it is only used in cases where conventional treatment cannot help, even though biological treatment could be a permanent solution for a much larger portion of patients.

The high cost and limited availability of biological treatment are not disadvantages of biological drugs themselves, but rather a disadvantage of our healthcare system.

Let's start with the basic concepts.

• An original drug is a medication that contains a new active substance. A tremendous amount of resources is spent on its research and development, which is reflected in its higher price. This drug also has patent protection (usually for 10 years after entering the market), which ensures that no one else can manufacture it. Patent protection is intended to help recoup the investment in drug research and development.
• When patent protection expires, other drug manufacturers can start producing the original drug under their own brand – a generic drug. The costs of bringing a generic drug to market are much lower than for the original drug, which means that generics are much cheaper. And cheaper drugs mean more accessible healthcare.
• A biosimilar is a "generic" biological drug. Why, however, is it not called a generic drug? Because a generic drug contains the same active substance as the original drug, while a biosimilar contains a substance very similar to the original drug (similar = similar). However, this does not mean that it is a different or lower-quality drug.

Why aren't biosimilar drugs identical to the originals? Simply because it is not technologically possible yet. Despite slight differences in structure, the effect of a biosimilar drug must correspond to the effect of the original biological drug, as demonstrated during the drug registration process.