Binnopharm’s production site in Moscow has passed the inspection by the Ministry of Industry and Trade of the Russian Federation and has received a GMP certificate from the Eurasian Economic Union for the production of monoclonal antibodies, according to mos.ru.
“The Binnopharm plant has received permission to manufacture monoclonal antibodies and is going to introduce the first drug of this series to the market next year. The production of the substance has already begun at the site,” said Anatoly Garbuzov, head of Moscow’s Department of Investment and Industrial Policy.
Monoclonal antibodies are crucial lab-made proteins that act as targeted drugs for cancers, autoimmune diseases, infections, and more. The company plans to launch its products in the first six months of 2026. The first biotechnological drug to be released by the plant will be adalimumab, a biological immunosuppressant, a biosimilar of Humira from the American AbbVie. Adalimumab is used for more than 10 medical conditions, including rheumatoid arthritis, psoriasis, Crohn’s disease, and Behcet’s disease. The facility is expected to produce about 10,000 packages of the drug annually.
According to the State Register of Medicines (GRLS), there are three tradenames of Humira biosimilars in the Russian market: Exemptia (PSK Pharma), Dalibra (Biocad), and Adalimumab (Pharmapark).
