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A biosimilar is a biological medicinal product that is highly similar to another biological medicinal product that was previously approved (the so-called "reference" or "reference" drug).

Animal cells, bacteria, viruses, fungi, and yeast are mainly used for the production of biological products using recombinant DNA technology and hybridization.

The primary structure of recombinant biologics is amino acid sequences. In the future, they are stabilized by disulfide bridges (secondary structure), in conclusion, the drug acquires a tertiary structure, and many proteins undergo glycosylation, which creates many isoforms that differ in the place of glycosylation and the length of carbohydrate chains. Such a complex structure, despite the use of modern methods that include control over the source of cells, the process of cultivation, purification, post-translational modification, etc. it cannot be made identical, but only analogous.

When reproducing a biological product, there may be minor differences from the reference product. These minor differences are not clinically relevant, i.e. differences in safety and efficacy are not expected. Natural variability is common to all biological medicinal products, and strict control measures are applied to ensure that it does not affect the method of operation or safety of the medicinal product.

Approval for the use of biosimilars is granted in accordance with the same standards of quality, safety and efficacy of medicinal products that apply to all approved biological medicinal products.

Demonstrating biosimilarity, a biosimilar can be based on the safety and efficacy indicators obtained when using a reference drug. This avoids unnecessary repetition of clinical trials already conducted with the reference drug.

The evidence obtained over 10 years of clinical experience demonstrates that biosimilars approved by the EMA can be used as effectively and safely as other biologics according to the appropriate indications for use.

The demonstration of biosimilarity is based on comprehensive studies of comparability with the refrain drug.

If the biosimilar is highly similar to the reference drug, and has comparable efficacy and safety for one therapeutic indication for use, data on safety and efficacy can be extrapolated to other indications for use that are already approved for the reference drug. Extrapolation should be supported by scientific data obtained from comparability studies (quality, preclinical and clinical).

Extrapolation is not a new concept, but it is a well-established scientific principle that is already being used routinely when biologics with several approved clinical indications for use are undergoing significant changes in their manufacturing process (for example, due to the introduction of a new formulation). In most of these cases, repeated clinical trials are not required for all indications for use, changes are approved based on quality studies and in vitro comparability.

All indications for the use of biological medicinal products (including biosimilars) were established on the basis of convincing scientific evidence.

The safety of biosimilars is monitored through ongoing pharmacovigilance measures, just as in the case of any other medicinal product. There is no separate safety requirement that applies only to biosimilars because of the different way they are designed.

Over the past 10 years, the EU monitoring system has not identified any relevant differences in the nature, severity or frequency of adverse events of biosimilars and their reference drugs.

The competitiveness of biosimilars can provide an advantage to countries 'health systems, as they are expected to increase patients' access to safe and effective biologics with proven quality.

Comparison of generic and biosimilar development characteristics
Generic medicinal product	Biosimilar medicinal product (biosimilar)
As a rule, it is produced by chemical synthesis.	It is obtained from a biological source.
As a rule, it is possible to obtain exactly the same molecule.	It is possible to reproduce the molecule with a high degree of similarity, thanks to unique biological production methods and natural biological variability.
Basically, smaller molecules that are easier to characterize.	Basically, larger molecules with a more complex structure, which require numerous technologies to compile their characteristics.
The need for complete data on pharmaceutical quality.	The need for complete pharmaceutical quality data, plus additional quality studies that compare the structure and biological activity of the biosimilar with the reference drug.
Development based on demonstration of bioequivalence (i.e. that the generic and reference drug release the active substance into the body at the same rate and to the same extent under similar conditions).	Development based on the demonstration of biosimilarity using comparability studies (a comprehensive direct comparative study of a biosimilar with a reference drug to demonstrate a high degree of similarity in chemical structure, biological function, efficacy, safety and immunogenicity)

Лоридамин (Бензидамин) 0,15% 30 мл оральный спрей

Pharmacovigilance

Лоридамин (Бензидамин) 0,15% 30 мл оральный спрей

Pharmacovigilance

Key features of biosimilars:

About the safety of biosimilars

Why biosimilars are not considered generic drugs

Meaning of biosimilars

For patients

For clinicians

For political figures, advisers, and representatives of government agencies and health insurance companies

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