The term “biosimilars” sounds like something directly from a science fiction novel, but luckily they are real progress in medicine. However, in order to better understand them, we first have to understand a kind of medicine called Biologics. So let’s get up again.
Most medicines that take people are small molecules, which means that they have a simple chemical structure and make it relatively easy. This includes many common medication such as aspirin and antibiotics.
Biologics are another newer kind of medicine, which consist of large organic macromolecules, usually proteins. They are much more complex than small molecule medication. Examples of biologicals are immunotherapy for the treatment of cancer, stem cell therapies for a variety of complex diseases and vaccines to prevent infectious diseases.
Understand biologics
“Biologics are medication from living cells thinking of proteins such as antibodies, hormones or enzymes,” said Annie Depasquale, MD, of the board-certified and founder in collaboration docs. “Traditional medication (like most tablets) are small, chemically synthesized molecules with identical stacks to batch. Biologics are grown in living systems, so of course they are more variable and require extremely tight quality controls.”
Imagine this: Every chemical is like a component. Put a few blocks together in a certain way and you will receive a small molecule medication. Anyone who has the same building blocks and puts it together can create a precise copy of the original. If this is done in the world of medicines in small molecules, we receive generic medicines. They are exact copies of original medication from brands – only without the brand, which usually makes it cheaper.
Biologics are much more complicated. Instead of a simple structure from a few dozen chemical building blocks, these macromolecules have thousands of parts in a very complex arrangement. The production of a biological drug requires much more than clicking on every piece. They are organic compounds and must be manufactured in living cells using DNA technology.
If you create a copy of a biological increase in access to this therapy, you will receive a biosimilar, therapy that is equally safe and effective for copied therapy. However, there are differences in the structure. Remember how to bake bread. You can use the same ingredients and follow the same recipe, but every bread loaf is a little different. The biosimilar copies of biological are not identical to the original, but they are very similar. The most important thing is that you have the same security and effectiveness.
From biologicals to biosimilars
Generics offer us access to the same treatments at lower costs. Biosimilars such as generics make certain advanced treatments more affordable and accessible.
Biologics are very expensive. It can take over 10 years and cost billions of dollars to develop a single biologist. These costs are passed on to patients and insurers. “Even after the competition, the biologicals remain cost -intensive than most pills where biosimilars immerse themselves in order to reduce the costs,” said Depasquale.
Biosimilars are not exactly cheap: they also need years to develop and still cost millions of dollars. However, the total development costs are much lower than an original biologist. So they can be approved for faster and with fewer costs. This cost reduction could even make some differences. People in historically marginalized groups, especially if they have public insurance, are less likely their recipes for biologicals. With more affordable biosimilars, more people can benefit from advanced medication.
How biosimilars are made
iStock.com/alernon77
Like biologicals, biosimilars are carried out by a complex process using DNA technology.
First, the genetic code for a certain protein is inserted into living cells. These cells can be yeast, bacterial, plant or animal cells. The cells “read” the code like a recipe and then get to work to produce large amounts of the protein. They are like billions of tiny organic kitchens. And they have high standards. The environment must be strictly controlled so that the conditions are correct. As soon as the cells have created the protein, it is isolated and cleaned for use as a biosimilar medicine. These drugs can then be handed over to patients as injections or IV infusions.
Bioequivalent advantages
So are biosimilars as safe and effective as the original biologicals? The answer is. “Biosimilars go through a strict FDA check using an approach of” Evidence “,” said Depasquale. “This includes analytical tests to show a high similarity to examine how the medicine behaves in the body, immunogenicity evaluations (risk of the body’s reaction reacts to the protein) and at least one clinical study in order not to confirm meaningful differences.”
A biosimilar must be viewed very closely to the original biological (referred to as a reference product) in order to be considered bioequivalent:
- It must be produced with the same type of natural materials.
- The reference product must match the molecular structure.
- It must be as safe to use.
- It must offer the same treatment advantages.
- It must have the same strength and dosage.
- It must be administered in the same way.
Conclusion: Biosimilars have no clinically meaningful difference to the original reference product. You work the same way. They offer the same advantages. “In head-to-head comparisons, biosimilars emerge equally with their reference products under the conditions they are to be approved,” said Depasquale. “Many patients converted from a reference biologist to a biosimilar without loss of effectiveness or new security problems.”
What do biosimilars treat?
Biologics and biosimilars can “treat a wide range of diseases that [have a greater impact on] Women or often in the middle of life, ”said Depasquale:
Biosimilars are advanced medication and can imitate natural biological processes in the body. They target certain cells and bind themselves to certain cells, interact with proteins and blocks or trigger immune responses. So they are very useful to prevent certain cells from doing the things that lead to diseases or spreading diseases. With the reduced costs and increased access to biosimilars, more women can get the best possible treatment to lead their best life.
This educational resource was created with the support of Sandoz.
From their site articles
Related articles related to the web