In Moscow pharmacies there was a shortage of the drug “Metypred” based on methylprednisolone

The departure of the Finnish Orion Pharma from the Russian market led to the disappearance from pharmacies of the company’s drug “Metypred” based on methylprednisolone, prescribed to patients with rheumatic diseases. The Ministry of Health does not yet see any particular problem, noting that the medicine that has become scarce can be replaced with prednisolone. But the association that brings together patients insists that for a third of patients, or more than 180 thousand people, switching to another drug is unacceptable and therefore they risk being left without proper treatment.

In Moscow pharmacies it is impossible to find methylprednisolone tablets used in the treatment of rheumatic diseases – “Metypred” by Orion Pharma or “Medrol” by Pfizer, I found “Kommersant” in the data of the Aptekamos reference book, the Apteka.ru service and the websites of large pharmacy chains, including “Rigla”, “ April”, “36.6”, “Zdorov.ru”. According to RNC Pharma estimates, in January-November 2023, 74 thousand packages of methylprednisolone tablets were put into circulation – this is 17 times less year-on-year and 86 times less than during the same period in 2021.

At the same time, in January-November 2023, only Medrol was introduced into circulation, but in a volume half as much as in the year before, while Metipred, which held a market share of 92.4% in volume terms back in 2021, did not reach the market at all. The situation is not the best with government procurement of methylprednisolone-based drugs. According to Headway Company, in 2023, 60% of all announced state tenders for the purchase of this product in tablets did not take place.

The problem with the shortage of the drug was confirmed by Kommersant and the Russian Rheumatological Association (RRA) Nadezhda. The Ministry of Health told Kommersant that the stocks of methylprednisolone in hospitals will last for 7.3 months, in pharmacies – for 1.2 months. The ministry believes that methylprednisolone in tablets at a dosage of 4 mg can be replaced with prednisolone in the same form at a dosage of 5 mg, citing the statements of the head of the rheumatology department of the National Medical Research Center for Children’s Health, Ekaterina Alekseeva, and the director of the National Medical Research Center for Rheumatology. V. A. Nasonova Alexandra Lila.

But for approximately 30% of patients such a replacement is impossible, says Polina Pchelnikova, vice-president of the Nadezhda RRA. According to her, prednisolone turns out to be “either ineffective or unsafe.” Thus, according to the association’s estimates, about 182 thousand people with rheumatic diseases in Russia risk being left without proper treatment. Methylprednisolone tablets are also used in the treatment of skin diseases and allergies.

Pfizer told Kommersant that supplies of drugs containing methylprednisolone are carried out regularly. But until 2023, Pfizer’s Medrol market share was extremely low, and even maintaining supplies will not solve the problem of drug shortages, Ms. Pchelnikova believes. According to Headway Company, Medrol’s share in government procurement does not exceed 3%.

Orion Pharma left the Russian market in 2023 amid the military conflict between the Russian Federation and Ukraine, but it was unknown whether supplies of the company’s products would continue. The rights to some of Orion’s drugs, for example the Regidron line of drugs for the treatment of gastrointestinal disorders, were purchased by Valenta Pharm (see Kommersant, July 17). In September 2023, Orion re-registered the registration certificate for Metipred to Finn Pharma, which was created at the end of 2022, as follows from the state register of medicines. The owners of this company are not disclosed.

Finn Pharma explained to Kommersant that Orion Pharma has completely stopped supplies to Russia. In December, the Federal Antimonopoly Service refused to allow Finn Pharma to increase the maximum price for Metipred by 163–173%, according to the department’s materials. The company indicates that they could consider supplying methylprednisolone tablets in imported packaging from other markets, but “there are a number of restrictions for this.”

The Ministry of Industry and Trade told Kommersant that Finn Pharma is carrying out a number of “measures to localize the production of methylprednisolone in the Russian Federation.” They also added that Pharmasyntez completed research on the generic Medrol at the end of 2023 and submitted an application to register the drug.

Polina Gritsenko