What are biosimilar medicines and why are they necessary in public health systems

Before delving into what biosimilar medicines are, it is important to clarify other concepts. In general, medicines are divided into two groups based on their origin: chemical synthesis drugs (aspirin, paracetamol, ibuprofen, etc.) and biologically derived drugs (hormones, antibodies, heparins, vaccines, etc.).


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These last, obtained by biotechnologybegan to be marketed in the 1980s for the treatment of diseases such as diabetes, multiple sclerosis, some types of cancer, rheumatoid arthritis or autoimmune diseases thanks to their ability to precisely attack the mechanisms and cells responsible for the progression of these diseases.

Due to their complexity when obtaining them (it is necessary to link thousands of different atoms together in a specific order in a special way, until the exact structure of the protein is achieved), biological medicines are included in the list of “medicines subject to additional monitoring”, belonging to the EU pharmacovigilance system.

Many of the patents of the first of these medicines have already expired, and others will do so in the next ten years, which means that copying them is no longer prohibited and that similar medicines can be marketed if they are shown to the health authorities that they are of the same product. And this is where the biosimilar drugs.

What are biosimilar medicines

To understand a little better what biosimilar medicines are, we can think of a biosimilar medicine as being to biological medicines as generics are to traditional chemically synthesized medicines.

But with a difference important: The natural variability and the greater complexity of the manufacturing process of biological drugs do not allow an exact replication of molecular heterogeneity. Therefore, biosimilar medicines cannot be copied exactly the same as biological medicines, as generics do, as the European document on biosimilar medicines clarifies.

To check that two proteins are sufficiently similar, activity is measured and compared in experiments and clinical trials in patients. Yes both produce the same beneficial effect and no differences arise in terms of tolerance or safety, they are considered biosimilar medicines.

A biosimilar medicine closely resembles another biological medicine already authorized in the European Union (called a “reference medicine”), according to the European Medicines Agency (EMA).

These are small differences of little clinical significance and therefore no differences in safety and efficacy are expected either.

The manufacture of biosimilars is based on different living organisms, and each manufacturer has to develop its own process independently. So, a biosimilar medicine and a biological medicine are similar, but not identical.

Any small change is controlled by the EMA, and any differences between the biosimilar medicine and its reference medicine have to be kept within strict limits to ensure that they both work in the same way.

From a legislative point of view, biological medicines and biosimilars are subject to European Directive 2001/83/EC relating to medicinal products for human use.

The EMA drafted specific European guidelines for the marketing authorization of biosimilar medicines in 2006. In the same year, the European Commission approved the first biosimilar medicine.

What are biosimilar medicines used for?

The development of biosimilar drugs aims to provide a most accessible answer to the treatment of patients with serious diseases such as cancer and inflammatory diseases.

The same ones that are treated with biological medicines: in addition to cancer, diabetes, or rheumatoid arthritis They are also used for osteoarthritis, osteoporosis, thrombosis, inflammatory bowel diseases, anemia associated with chronic kidney failure, dermatological diseases and fertility treatments, among others.

In both biological drugs and biosimilars, the route of administration and posology (dosage) must be the same. Currently, and since they were first approved in 2006, some of the biosimilar drugs marketed are erythropoietins, growth hormones, insulin, heparin, rituximab, trastuzumab, infliximag, etanecept, etc.

In the early days, these drugs had a restricted use in the hospital setting, until in 2015 they began their journey in Primary Care. Despite this progress, its consumption is still focused mainly on hospitals.

A timid but important step because biosimilars allow a greater number of patients to access biological treatments because have a lower cost.

The commercialization of biosimilar drugs, their incorporation and use, supposes a reduction in acquisition costs that favors the sustainability of health systems.

First, because they have a lower price since the scientific knowledge that has been obtained from the original medicine is used, and second, because they promote competition in the market and, therefore, the reduction of the price of the original medicines.

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