Aksiniya Titova

A biosimilar instead of the original. This is what Kazakhstani diabetics are going to «inject».

A biosimilar is a biological product that is almost identical to the original drug and is produced by another company. Essentially, this is a bioanalogue that is an approved version of the original «innovative» drugs. They are usually produced when the patent for the original drug expires. Some experts call biosimilars the drugs of the future, while others openly criticize them, explaining that analogs cannot compete fully with the originals.

Expectation Becomes Reality

Recently, Kazakhstan purchased a new batch of insulin. However, instead of the long-awaited European drug, a Chinese one was brought into the country. This drug is new; it has undergone one study only, and only in China. In Kazakhstan, it has also undergone small clinical trials. It is too early to talk about its effectiveness, but this fact already raises concerns among patients with diabetes and even among medical professionals. We are talking about the drug «Rapilin».

The first to raise the alarm was Majilis deputy Gul’dara Nurumova. At a Majilis meeting on March 18, she emphasized that the new insulin for Kazakhstani patients has not undergone clinical trials, yet, for some reason, representatives of the Ministry of Health deemed it «sufficiently high-quality» to supply it to Kazakhstan as part of free medical care.

«Its effectiveness is still unknown, it has not undergone clinical trials. Doctors and patients are outraged. We are talking about the health of our citizens. Why can’t we purchase a high-quality European drug?!» — Gul’dara Nurumova asked and explained:

«The most important concern is how the drug will behave after its administration, what consequences can there be? Because the lack of complete study cannot guarantee absolutely positive results without side effects. Biosimilars can cause any side effects,» said deputy Nurumova.

Why did the Ministry of Health purchase this drug? The answer is obvious: because biosimilars are at least 15% cheaper than originals. That’s how «Rapilin» won the tender at the end of last year.

But it is unknown how saving the state budget will affect the health of Kazakhs who rely on insulin…

Money or Life?

As Kazakhstani doctors explain, a wrongly chosen drug for diabetic patients can cause a range of side effects, up to the patient’s death.

Kazakhstani diabetics have already faced sudden changes in medication. As Kazakhs with this diagnosis tell journalists, in early 2019, they were already being subjected to «experiments» when an Indian drug was brought into the country. It was almost impossible to use it because the pen-syringes fell apart, without which patients could hardly self-administer the drug. Now, when patients will be supplied with the Chinese biosimilar, many are also planning to buy insulin themselves. It may be expensive, but it is safer. Insulin preparations cost from 17,000 tenge in Kazakhstani pharmacies.

Doctors are most concerned about the health of children with diabetes in Kazakhstan, as there are still no proven algorithms for the use of biosimilars in our country.

Involuntary Test Subjects

In addition, it is alarming that in global practice, in countries where drugs undergo serious scrutiny, only a small number of biosimilars are permitted for automatic substitution. «Rapilin» is not on this list as of today.

Some experts, for example, Akmara Al’nazarova, claim that Kazakhstani patients have not experienced any side effects from the Chinese insulin. According to her, the first batch of the Chinese drug was purchased last year, and supposedly, for a year, no one has complained about the insulin.

In response to this, Ruslan Zakiev, Director of the Public Foundation «Diabetic Parent Committee,» explained that this statement is not entirely true. According to him, the drug was purchased at the end of last year, and patients are only now starting to receive it. Therefore, it is too early to talk about its safety, let alone effectiveness. We’ll see, but for now, Kazakhs will have to be selective about the drugs they receive, provided that their financial situation allows them to choose.