What are biological and biosimilar medicines?

Biologics and biosimilars have marked a milestone in the prevention and treatment of serious diseases such as cancer and multiple sclerosis. What are they, what are they used for and what differentiates them from each other?

Last update: September 26, 2021

Much is said about biological and biosimilar medicines, but it is not always clear what the differences between them lie in, which ones are better or why some are prescribed and not others. The role that generics play in all this is not well identified either.

Let's start by saying that biological and biosimilar medicines are safe products that meet the requirements established by science and official bodies. When a patient switches from one to the other, he shouldn't notice any difference.

Biosimilar medicines are so called because they are very similar to the biological one of origin. However, they have a much lower cost, which does not mean less quality. In a moment, we will see what biological and biosimilar medicines are and why they are both safe and effective.

What are biological medicines?

Biological and biosimilar medicines are different from each other, but both are effective in treating different diseases.

Biological medicines are those that are made from living organisms such as animal cells, yeast or bacteria. In general, they are more complex than other drugs. Purification, processing, and manufacturing of these medicines are more complicated than others.

These drugs have had a major impact on the prevention and treatment of serious, chronic, and life-threatening illnesses. Within them rheumatoid arthritis are counted, multiple sclerosis, autoimmune disorders, and cancer.

The manufacturing process for biological medicines is very sensitive. As they are made from live inputs, these vary naturally. Because, there may be differences between two batches of the same medicine. This requires additional procedures to be carried out so as not to affect the safety and efficacy of the product.

What are biosimilar medicines?

Biosimilars are biological drugs very similar to the original. They do not have significant clinical differences in relation to the reference medicine. The properties, safety and efficacy are almost the same.



What differentiates biological and biosimilar medicines is, first of all, that the former are the originals, while the latter are rough copies of these. Second, the process they go through for approval is different.

To develop a biological medicine, clinical trials must be carried out to test its safety and efficacy. Instead, biosimilars must prove that they are sufficiently similar to the original drug, that is to say, to the biological one.

Therefore, biological and biosimilar medicines must be used to treat the same pathologies. These include cancer, diabetes, rheumatoid arthritis, anemia associated with kidney failure, inflammatory bowel diseases, etc.

Relationship between biosimilar medicine and generic medicine

Biosimilar and generic medicines have in common the fact that both are replicas of other medications that are original. Therefore, the process for their validation is similar: they must demonstrate that they are still as safe and effective as the reference medicine.

However, generic drugs are developed from a process of chemical synthesis. Instead, biosimilars start from a biological source. While the generic is an exact chemical copy of the original, the biosimilar is a relative replica that it starts from the same live source of the reference medicine.

Secondly, the biosimilar must obtain special approval before it can be used as a substitute for the biological. The generic, for its part, can be automatically replaced by the original, without any additional approval.

Is it safe to take biosimilar medicines?

Biological and biosimilar medicines must have the same quality, safety and efficacy. In both cases, and as with all types of medications, they can also give rise to unwanted immune reactions or adverse effects.

It must be said that biological and biosimilar medicines can cause an allergic reaction. This is largely due to the fact that its molecules are larger. The reaction is known as "immunogenicity." Therefore, patients who use them must undergo detailed monitoring.

That said, it should be noted that the two types of drugs use the same biological source, are administered in similar ways, have the same strengths and dosages, and provide the same benefits. Biosimilars are only approved after thorough reviews.

Can I take a biosimilar if I started the original treatment?

Treatment will be determined by the physician and must be adhered to from start to finish.

At first, biological and biosimilar medicines cannot be exchanged automatically. The substitution can only be made after a doctor, or an authorized professional, specifically prescribes it, if he considers it interchangeable.

There are countries in which the exchange can only be carried out within the framework of hospital care. This is because in such an environment detailed monitoring of possible reactions to change can be guaranteed.

In other countries it is possible to change from a biological to a biosimilar in primary care. The common thing, in any case, is the fact that a medical authorization is required to carry out the substitution of one for another.



Considerations and Recommendations

Sometimes a person does not know whether he is using a biological medicine or a biosimilar one. It is advisable to speak with the doctor who is administering the treatment to clarify this point. In this way, you have more awareness of the process.

If a person is being treated with a biological medicine, they also you can ask your doctor if there are any biosimilars that you can use. This is relevant, especially in cases where health insurance does not cover these products.

It is of utmost importance that biological and biosimilar medicines are applied or ingested as directed by the doctor. In these cases, even more than in others, it is necessary to adhere to the instructions of the healthcare provider.

Biological and biosimilar drugs, two viable treatment options

It is very likely that biological and biosimilar medicines will be increasingly available in the coming years. These have proven to be very safe and effective, but you don't always have access to them.

Due to its complexity, biological medicines are often very expensive. With the introduction of biosimilars, it is possible to reduce the price and achieve that many more people have access to this type of medicine.