Signifor and Zeposia registration withdrawals expose different supply risks in Russia

Manufacturers requested both cancellations

Russia’s Ministry of Health has confirmed that the registrations of Signifor and Zeposia were cancelled at the request of their manufacturers, Kommersant reported. Both medicines had been included in Russia’s list of vital and essential drugs, but their removal presents markedly different risks for patients and the pharmaceutical supply system.

Signifor, a subcutaneous solution supplied by Recordati Rare Diseases, contains pasireotide, a synthetic analogue of the hormone somatostatin used to treat Cushing’s disease. Zeposia, supplied by Celgene International SAR in capsule form, is an immunosuppressant used for multiple sclerosis and severe ulcerative colitis. Media reports about their planned exclusion from the state medicines register appeared in late August.

Rusfic, which represents Recordati Rare Diseases in Russia, told Kommersant that Signifor’s withdrawal formed part of the company’s ongoing product-portfolio management and optimization. It said the decision was unrelated to the drug’s quality, efficacy or safety. Celgene International SAR had not responded to Kommersant by the time of publication.

Signifor demand has shifted to osilodrostat

Nina Petunina, head of endocrinology and metabolic health at Sechenov University, said doctors now use osilodrostat for the medical treatment of Cushing’s disease. The medicine, also produced by Recordati Rare Diseases, directly blocks cortisol production in the adrenal glands. It is prescribed to adults as second-line therapy when neurosurgery is ineffective or cannot be performed.

According to Petunina, osilodrostat demonstrates efficacy of 76–86%, compared with 40% for pasireotide. Patients may also receive the long-acting Signifor LAR formulation, which is injected intramuscularly once every 28 days. However, Signifor LAR is not yet registered in Russia and can only be procured following a medical council decision at a federal medical centre. Rusfic said Recordati Rare Diseases is preparing registration documents.

Kirill Kulayev, head of legal affairs at the rare-disease organization Dom Redkikh, said the withdrawal had not reduced the quality of care because Signifor had effectively not been procured since 2025 and patients had already moved to osilodrostat.

Procurement data show contrasting exposure

Russia’s medicine-tracking system recorded pasireotide purchases of RUB17.7 million, or 99 packs, in 2024. Purchases during the first seven months of 2026 amounted to RUB7.9 million for 41 packs. Osilodrostat procurement reached RUB131 million and 16,900 packs over the same 2026 period, compared with RUB65.4 million and 4,600 packs during all of 2024.

Zeposia procurement was smaller: 69 packs worth RUB3.5 million in 2023 and 29 packs worth RUB3.8 million in 2024. No purchases were recorded in 2025 or 2026. The limited volumes do not eliminate the clinical concern because multiple sclerosis is a chronic condition requiring continuous therapy.

Zeposia has no automatic replacement

Pharmaceutical expert and Pharmedu chief executive Tatiana Khodanovich told Kommersant that Zeposia has no automatic substitute on the Russian market. Patients who had been taking it may therefore face a difficult period of adaptation and must review their treatment with their physicians. She said regulatory intervention was needed to prevent interruptions in therapy.

Khodanovich linked the broader trend to foreign manufacturers withdrawing products that are no longer economically viable in Russia, alongside the Ministry of Health’s effort to remove registrations from the state register. She said the ministry cancelled 23 drug registrations in summer 2026. The departure of foreign brands may create space for Russian producers and generics, but the transition is more difficult when a unique treatment or a medicine for a rare disease is involved.