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The term “biosimilars” sounds like something out of a science fiction novel, but fortunately they are real advances in medicine. But to understand them better, we must first understand a class of drugs called biopharmaceuticals. Let’s go back a little.
Most drugs that people take are small molecule drugs, meaning they have a simple chemical structure and are relatively easy to manufacture. This includes many common medications such as aspirin and antibiotics.
Biopharmaceuticals are another, newer type of medicine made up of large organic macromolecules, usually proteins. They are much more complex than small molecule drugs. Examples of biopharmaceuticals include immunotherapies to treat cancer, stem cell therapies for a variety of complex diseases, and vaccines to prevent infectious diseases.
What are biopharmaceuticals?
“Biopharmaceuticals are drugs that are made from living cells, i.e. proteins such as antibodies, hormones and enzymes,” explains Dr. Biopharmaceuticals are grown in living systems and are therefore inherently more variable and require extremely strict quality controls.
Think of it this way: each chemical is like a component. If you put several components together in a certain way, you get a small molecule drug. Anyone who has the same components and puts them together in the same way can make an exact copy of the original. When this happens in the small molecule drug space, we get generics. They are exact copies of the original, just like brand-name medications, but without the brand name, making them more cost-effective.
Biopharmaceuticals are much more complicated. Instead of a simple structure made up of a few dozen chemical components, these macromolecules are made up of thousands of parts in a very complex configuration. Preparing a biopharmaceutical requires much more than the correct addition of each element. They are organic compounds and must be produced in living cells using DNA technology.
When you make a copy of a biopharmaceutical to improve access to that therapy, you receive a biosimilar, a therapy that is just as safe and effective as the original treatment. However, there are structural differences. Imagine it was something like baking bread. You can use the same ingredients and follow the same recipe, but each piece of bread is a little different. Biosimilar copies of biopharmaceuticals are not exactly identical to the originals, but are very similar. What is important is that they have the same safety and effectiveness.
From biopharmaceuticals to biosimilars
Generics allow us to access the same treatment at a lower cost. Like generics, biosimilars make certain advanced treatments more affordable and accessible.
Biopharmaceuticals are very expensive. Developing a single biological drug can take more than ten years and cost billions of dollars. These costs are passed on to patients and insurers. “Even as several competitors begin production, biopharmaceuticals are still more expensive than most pills, and this is where biosimilars come in handy to drive down costs,” DePasquale said.
But biosimilars aren’t exactly cheap: They take years to develop and cost millions of dollars. But the overall development costs are much lower than that of an original biopharmaceutical. This means the deployment can be approved more quickly and with less effort. This cost reduction may help eliminate some differences. People from traditionally marginalized groups, especially if they have public insurance, are less likely to purchase the biopharmaceuticals specified in their prescriptions. With more affordable biosimilars, more people can benefit from advanced medicines.
How biosimilars are made
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Like biopharmaceuticals, biosimilars are manufactured through a complex process using DNA technology.
First, the genetic code for a specific protein is introduced into living cells. These cells can be yeast or bacteria as well as plant or animal cells. The cells “read” the code like a recipe and begin producing significant amounts of proteins. They’re like billions of tiny organic kitchens. And they have high standards. The environment must be strictly controlled so that the conditions are suitable. Once the cells produce the protein, it is isolated and purified to be used as a biosimilar drug. These medications can then be given to patients via intravenous injections or infusions.
Bioequivalent benefits
So are biosimilars as safe and effective as original biopharmaceuticals? The answer is yes. “The FDA [Administración de alimentos y medicamentos] “Evaluates biosimilars rigorously using an ‘all the evidence’ approach,” DePasquale said. “This includes analytical testing to demonstrate high similarity, studies of how the drug behaves in the body, assessments of immunogenicity (the risk that the body will react to the protein), and at least one clinical trial to confirm that there are no significant differences.”
To be considered bioequivalent, a biosimilar must have properties that are very similar to those of the original biomedicine (so-called reference product):
- It must be made of the same natural materials.
- The molecular structure must be very similar to that of the reference product.
- Its use must be equally safe.
- It should provide the same therapeutic benefits.
- It must have the same concentration and dosage.
- It should be administered in the same way.
In other words: Biosimilars show no clinically significant difference to the original reference products. They work the same way. They offer the same benefits. “Comparing the two products, the biosimilars perform equivalently to the reference products for the conditions for which the treatments are approved,” DePasquale said. “Many patients have made the switch from a reference biomedicine to a biosimilar without loss of efficacy and without new safety concerns.”
What do biosimilars treat?
Biopharmaceuticals and biosimilars can “treat a wide range of diseases.” [tienen un gran impacto en] Women or who often appear in middle age,” DePasquale explained:
Biosimilars are advanced medications and can mimic natural biological processes in the body. They target and adhere to specific cells, interact with proteins, and block or activate immune responses. Consequently, they are very useful for preventing certain cells from doing things that worsen or spread disease. With lower costs and greater access to biosimilars, more women can receive the best treatment possible to live the best version of their lives.
This educational resource was created with the support of Sandoz.
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