The originals and copies. Why you need a medicinal clones

Our expert – President of League of patients, the expert of the Russian Academy of Sciences, member of Expert Council under the Government of the Russian Federation Alexander Saversky.

Today has been quite a buzz about the latest innovative biological products for the treatment of serious illnesses who have committed a real revolution in medicine. It is believed that the biotechnology and biologics the future of medicine, and that they are the salvation for many seriously ill people whose illnesses 15-20 years ago was incurable.

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Alive – to prolong life

Biological medicines are produced by living organisms during complex processes. Their active ingredients are mainly proteins: hormones, antibodies, insulin (perhaps the most famous of biologics).

Someone biological products allow you to fully heal, but in most cases, with their help it is possible to translate a fatal disease into a chronic one, extending the life of the man for years, and even decades, while not reducing its quality. Some biologics are used to treat chronic diseases, such as cancer, diabetes and rheumatoid arthritis, other for the treatment of acute diseases – heart attack, stroke.

According to scientists, future progress in medicine will depend on application of biological drugs more effective and safe, selectively acting on pathological processes in the body.

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No one is indispensable?

Wide application of biological drugs currently limited by two factors – their immunogenicity (ability to induce an immune response of the body, which can lead to a change in efficacy or adverse reactions) and their relatively high cost. And here lies a serious problem which is not yet possible either to Russia or to other countries. Since such treatment costs the state dearly, it has attended to search of cheaper alternatives, one of which, i.e. biosimilars, medicines that are already with someone’s easy hand began to name biogenetically. The goal is declared good: to make modern medical treatment more affordable. But how much will a full replacement (or substitution?) and can it happen that the miser will have to pay twice?

As a copy of the medication?

The effects of the treatment, i.e. biosimilars are not yet fully understood. However, they are frequently prescribed to patients in different countries. The main reason for such appointments, as is acknowledged by all specialists, not medical, and economic factors.

Cases of deterioration of patient while translating it from the original biological product on the bioanalogue has already recorded a lot – in the UK, Germany, Czech Republic and other countries. If they are in Russia, but statistics are known only to a narrow circle of specialists. Experts are sure, i.e. biosimilars have to undergo research on quality and safety, preclinical and clinical studies to confirm their conformity to certain criteria.

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Similar, but not identical

About generics – exact copies of traditional drugs, just standing much cheaper than the original drug, is certainly heard by many, and many buy them and take as directed by a healthcare practitioner. With bio analogues and their therapeutic effect while a complete lack of clarity even among physicians themselves.

All the same, i.e. biosimilars are copies of original biological products, in the best case, they just like them. Manufacturing biologics is a complex process: if the process of obtaining active ingredients in conventional drugs – chemical synthesis – includes more than 100 stages, the biologics are more than 5,000 stages. Traditional drugs composed of small molecules and not too complicated, and biological products include hundreds of thousands of amino acids.

Biological products ripen in the process of a carefully controlled large-scale fermentation in specially designed bioreactors. This is followed by purification of the resulting protein formulation and manufacturing of the finished product. All of the above makes the production process is so complex that any, even small changes in any part of this process can significantly change the composition of the mixture of proteins and thus to modify the properties of the finished drug.

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Ask for the original

It turns out that an exact copy of an original biological product is impossible, at least at this stage. Concepts such as biogeneric does not exist, scientists believe.

If the doctor writes a patient a bioanalogue, to achieve the purpose of the original drug only by the decision of the medical Commission in the presence of medical indications. For example, if you are hypersensitive bioanalogue or for health reasons (this should be reflected in the medical records). Otherwise to the original drug instead of analog it is possible, alas, only at their own expense.


The first biological drug to the growth hormone was produced by genetic engineering using microorganisms in 1977 and was intended for children with deficiency of this hormone. Then in 1986 came the biologic erythropoietin to treat anemia in patients with chronic renal failure. Then there were recombinant interferon-alpha is an effective remedy against viral infections, particularly chronic hepatitis. But when about 15 years ago in the pharmaceutical market appeared EN masse biological drugs for treatment of socially significant diseases – cancer, heart attack, stroke, rheumatoid arthritis, – talking about the revolution in medicine.

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