FC Grand Capital to supply analogues of Gettestiv from PSK Pharma and Promomed

The contract also states that a total of 133,840 vials of teduglutide in the form of a lyophilisate for the preparation of a solution for subcutaneous administration with the Teduglutide PSK TN from PSK Pharma, as well as 133 thousand vials of Teduglutide from Promomed Rus will be supplied. Deliveries must be completed by the end of 2025.

The tender for the supply of teduglutide with an initial maximum price of 2.3 billion rubles was announced by the Federal Center for the Prevention and Control of the Diseases of the Russian Federation in June 2025. Three applications were submitted for participation in the auction - for 1.7 billion rubles, 970 million and 959 million rubles. In July, the FAS suspended the selection of a contractor based on a complaint from one of the auction participants - the distributor Pharmimex. As reported in the text of the complaint, the sale of generic drugs, for which data on preclinical and clinical studies of Gettestiv were used in their registration, is prohibited until June 2027. Promomed then told the media that it had never had access to the documents submitted by Takeda for the registration of any drugs, and, accordingly, could not use the information from them.

The relevant commission of the antimonopoly service reviewed the complaint and found it unfounded. The regulator's decision noted that the winner of the tender, FC Grand Capital, attached copies of the registration certificates for Teduglutide from Promomed and for Teduglutide PSK from PSK Pharma to its application.

The original Gettestiv was registered in Russia by Japanese Takeda in mid-2021, at the same time short bowel syndrome was included in the list of diseases whose treatment is financed by the Circle of Goodness foundation. In July 2021, teduglutide was included in the foundation's procurement plan. The arrival of the first batch of the drug in Russia became known at the end of 2021. Now the drug is purchased by regional departments and institutions, but the bulk of it is accounted for by the Federal Center for the Prevention and Treatment of the Diseases of the Russian Federation - since 2023, according to the Unified Information System "Procurement", the federal center has purchased Gettestiv for a total of more than 5 billion rubles.

In August 2024, the issue of including teduglutide in the list of vital and essential drugs was considered by the Commission of the Ministry of Health of the Russian Federation for the formation of drug lists. During the discussion, the chief freelance specialist - gastroenterologist of the Ministry of Health of the Russian Federation Vladimir Ivashkin noted that short bowel syndrome is typical, among other things, for combat injuries and injuries in road accidents, and advocated for the inclusion of the drug in the list. The Ministry of Health clarified that a domestic generic is at the registration stage. Takeda representatives proposed a price for the original drug - 1.3 million rubles. As a result, the overwhelming majority of commission members voted against.

Vademecum reported on the registration of the first generic of Gettestiv in Russia by PSK Pharma in early April 2025. The drug was registered under the TN Teduglutide PSK, and the active substance for its production, according to data from the State Register of Medicines, is supplied by the Indian MSN Life Sciences. Promomed received a registration certificate for its analogue under the TN Teduglutide in May 2025, the company planned to produce the pharmaceutical substance at its own enterprise Biokhimik.