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Russia's type 1 diabetics left without imported insulin as Swixx BioPharma cuts supplies to Russia

Russian diabetics are now attempting to cope without Humalog insulin, a trusted product from the world’s largest manufacturer, Eli Lilly. Swixx BioPharma has announced that Eli Lilly insulin shipments to Russia will end, and a company response to an inquiry from The Insider confirmed the news.

Content
  • What will replace Humalog?

  • Patients' reaction

  • What are biosimilars?

RU

The affected products include Humalog and its derivatives, which are available in both cartridge and pre-filled pen form. A Swixx BioPharma representative mentioned that the company is currently selling off the insulin stock remaining in its warehouses. Specifically, Humalog Mix 50 KwikPen and a small quantity of Humalog Mix 25 cartridges and pens are still available. An official letter from Swixx BioPharma clarified that U.S. pharmaceutical manufacturer Eli Lilly made this decision on May 23, 2024.

In March 2023, Eli Lilly entered into a rights transfer agreement with Swixx BioPharma to import and sell drugs in Russia. This was intended to fulfill current obligations related to local production.

“This agreement will continue to ensure the supply of essential medications to Russia for patients needing treatment for diabetes, oncology, autoimmune, and neurological diseases,” the company emphasized at that time.

In March 2022, in the immediate aftermath of Russia’s full-scale invasion of Ukraine, Eli Lilly announced the suspension of non-essential drug exports, investments, advertising activities, and new clinical trials in Russia.

According to a source cited by Kommersant, Eli Lilly’s transfer of business to Swixx BioPharma was an attempt to retain a significant portion of the company’s sales revenue from However, the American company’s exclusion from the Russian state procurement market had already begun. In 2022, its volume of state contracts for Humalog insulin amounted to 614.8 million rubles, 31% less than the previous year and 43% less than in 2020, according to Kommersant.

According to the same source, the deal with Swixx BioPharma was also seen as a potential opportunity to re-enter the Russian market should external political conditions improve. This scenario now seems unlikely.

Russia’s shift away from imported insulins was underway even before 2022. As early as 2015, under the guise of an import substitution scheme, Russia implemented its “third one out” principle. This policy excluded any foreign company from state drug procurements if two Russian companies were participating in the tender. In 2021, the rules were further tightened to the “second one out” principle, meaning that if a participating company conducted full-cycle production of a drug entirely within the territory of the Eurasian Economic Union (EAEU) territory, companies from outside of the bloc were automatically excluded from the bidding. This mechanism was, at least officially, aimed at accelerating the full-cycle production of strategically significant drugs closer to home.

In March 2022, Vladimir Gutenev, chairman of the Russian State Duma’s Committee on Industry and Trade, stated that insulin import substitution in Russia would reach 100% within a month. Although a month was not enough, within two years almost all imported insulins had indeed become scarce in the country.

As a result, in March 2024 Russian diabetics faced a shortage of the ultra-fast insulin Fiasp, produced by the Danish company Novo Nordisk. According to Kommersant, state procurements of this drug decreased by 95% in the first quarter of 2024 — practically ceasing altogether.

What will replace Humalog?

Humalog will be replaced by the Russian-made biosimilar RinLiz by Geropharm, a company owned by the family of former Gazprom top manager and former Russian Minister of Fuel and Energy Pyotr Rodionov.

“We aim to become the number one insulin supplier in Russia within the next two years,” said Geropharm’s head, Pyotr Rodionov Jr. in a July 2022 interview. And indeed, in that year Geropharm’s revenue reached 119 billion rubles ($1,333,364,060). According to RNC Pharma, as cited by Vedomosti, from January to October 2023, the company sold 65 million packs of medicines in Russia for 92 billion rubles ($1,030,849,880). By 2023, Geropharm became the main supplier of insulin in the government sector, alongside fellow domestic manufacturers Medsintez and Pharmstandard.

Government contracts are the primary source of profit for any insulin manufacturer. However, Geropharm's involvement in diabetic care extends beyond insulin. By the end of 2024, the company aims to sell one million Semavik pen needles, a drug designed for treating type 2 diabetes and aiding in weight loss — in other words, an analogue to Novo Nordisk's original drug, Ozempic. Peter Rodionov shared this information with Delovoy Peterburg during backstage discussions at the 27th St. Petersburg International Economic Forum.

Ozempic was under patent protection in Russia until 2035. However, at the close of 2023, Russian authorities issued two compulsory licenses allowing for the production of semaglutide-based medications developed by Novo Nordisk without the patent owner's consent. In St. Petersburg, Geropharm commenced the production of Semavik, while Moscow's Promomed initiated the production of Kvincenta. These licenses are valid for one year, but Pyotr Rodionov is already optimistic about their extension. “I anticipate that in 2025, the government will renew the compulsory license for all interested parties. As for 2026, it remains uncertain, but this scenario seems most likely for 2025,” he remarked.

Patients' reaction

Consequently, numerous Russian diabetics are compelled to transition from original imported insulins to domestic counterparts. The most affected group is type 1 diabetes patients, who rely on insulin as a lifelong therapy due to the fact that the loss of pancreatic beta cells means that their bodies cannot produce endogenous insulin. Many have relied for decades on the tried-and-tested Humalog, which is now unavailable on the Russian market. In its place, they are being presented with the RinLiz analogue from Geropharm.

The Insider reviewed chats in which parents of children with type 1 diabetes share their experiences with Russian drugs:

Good evening, whoever has RinLiz, please write. It works for 5 days and then it has no effect. Change the pen and it's normal again. Has anyone faced such a quick spoilage of insulin?”
Good afternoon. Please, could someone advise if they have encountered this situation? The distribution of Humalog has been discontinued. They are offering RinLiz. I have two children with type 1 diabetes. To be assessed by a medical commission, it is necessary to document adverse reactions in a hospital setting. I doubt they will write this down. We tried using RinLiz for my older son, and it didn't work. Sometimes it had no effect, sometimes it lowered his blood sugar uncontrollably. My son is on a pump. For Humalog, I had purchased a pen with 0.5 increments for my younger daughter. How can I ensure we get Humalog?”
Good afternoon. How to argue, they prescribe RinLiz but my daughter is intolerant, lumps and inflammation immediately appear. We buy Humalog ourselves, it has a better effect. Now she is in the Endocrinology Research Center, the doctor says she is not sure she is allowed to recommend a particular brand name, what else can we say or do?”
My situation: I've been on a pump since 2021. Initially, I was using Humalog. Then, of course, they started prescribing RinLiz, which works for the first couple of weeks and then has no effect. With Fiasp, by the fourth day, I start having headaches that don't go away (I've tried it three times). Apidra didn't work for me even when I used it with pens a few years ago. Now I went to see the chief endocrinologist, and she is sending me to the hospital to find a suitable type of insulin for me. I explained to her that I don't need another one, but she said there is no Humalog and there won't be any. Either I get hospitalized to find another insulin or else I’m on my own.”

Many patients are now willing to buy Humalog from private sellers abroad via “grey” schemes. The Insider spoke with Anna from Samara (name changed), the mother of a child with type 1 diabetes. She does not plan to switch from Humalog to another insulin. According to Anna, the cost of Humalog, which can be privately ordered from Germany and delivered to Russia, is as follows: a pack of five 3 ml pens costs 10,500 rubles ($118), plus 4,100 rubles ($46) for delivery. In total: 14,600 rubles ($164) per pack. Meanwhile, in Russia, such a pack of Humalog used to cost an average of 1,700–1,800 rubles ($19-20).

“We cannot afford to buy Humalog for nearly 15,000 rubles ($169) per pack, so we will explore purchasing options through Turkey,” says Anna. “There, the pharmacy price for Humalog is about 2,000 rubles ($23), but we will need to buy a year's supply to make the cost of delivery worthwhile, through people traveling there for vacation.”

And of course, insulins are far from the only expense for diabetics. Anna's son uses Omnipod wireless insulin pumps from the U.S. company Insulet, which are not registered in Russia and can only be purchased through private sellers. According to Anna, a month's supply costs 23,700 rubles ($267), and these are for pumps with an expired official shelf life, which sell for cheaper.

Victoria, the mother of a child with type 1 diabetes from Moscow, agrees with Anna:

“If you buy fresh Omnipods, it’s about 35,000 rubles ($394) a month, too expensive. We buy those with an expiration date up to 2023 — then it’s approximately 20-25,000 rubles ($225-280) a month.”

However, while many consider wireless insulin pumps a “luxury” for parents (since wired pumps are provided in Russia), original insulin cannot be seen as a luxury, notes Anna. “I am afraid to inject my child with biosimilars because we don't know what the long-term consequences will be. They haven't stood the test of time, unlike Humalog, which has been on the market for almost 30 years,” she told The Insider.

What are biosimilars?

Biosimilars differ from generics. The degree of similarity that exists between an original chemical drug and its generic is unattainable in the field of biotechnological products. But unlike with generics (analogues of chemically synthesized drugs), it is impossible to make a biosimilar identical to the original.

All modern insulin preparations are classified as biotechnological drugs. Medical biotechnology involves producing drugs from living cells, such as bacteria, viruses, yeast, or various tissue cell cultures. Unlike chemical drug synthesis, the creation of bioengineered drugs is highly sensitive to technological nuances. It requires meticulous selection and purification of substrates, strict adherence to temperature regimes, and the use of precisely defined solution concentrations.

Therefore, European specialists emphasize that the simplified registration procedure used for generics is unsuitable for biosimilars. The potential consequences of differences between a biosimilar and the original drug are unpredictable. Previously, Russian diabetics could circumvent biosimilars by purchasing the necessary original insulin from a pharmacy at their own expense, but that option is no longer available.

Maria Blokhina (Editor-in-Chief of the Telegram channel T1D News) specifically for The Insider



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