Generium has received a registration certificate for the first Russian biosimilar of canakinumab. The drug, Limiris, is presented as a lyophilized powder for subcutaneous injection. This information is available in the State Register of Medicines (GRLS).
Limiris, an analog of Novartis’s Ilaris, is indicated for the treatment of Still’s disease, systemic juvenile idiopathic arthritis, autoinflammatory diseases, and gouty arthritis. Canakinumab binds interleukin-1β (IL-1β), a protein that is a mediator of the inflammatory response.
The immunosuppressant canakinumab is included in the list of Vital and Essential Drugs (VED) list and is procured for the needs of the Circle of Kindness state charitable found. The biosimilar of the drug, Limiris, is produced in Russia on a full-cycle basis.
However, as experts state, it is not economically justified to produce all drugs in Russia from start to finish. A universal requirement for localization at all stages can lead to supply disruptions and a reduction in the range of available drugs. GxP News looked into the topic.