Rossium Subsidiary Seeks Russian Registration for Second Canakinumab Biosimilar After Belarus Approval
核心洞察
Belarus's Health Ministry has approved the first canakinumab biosimilar developed by BioImmunity LLC (搜索), a Rossium Group (搜索) subsidiary, marking the first monoclonal antibody copy produced in Belarus through a full manufacturing cycle.
The biosimilar dossier is now under pre-registration review by Russia's Health Ministry and, if approved, would become the second anti-IL-1β antibody biosimilar available in Russia for severe orphan diseases.
Phase I and Phase III clinical trials demonstrated pharmacokinetic equivalence, comparable safety, and therapeutic equivalence to Novartis's original drug Ilaris, with most gout patients experiencing attack resolution within three days.
Belarus's Health Ministry has approved the first canakinumab biosimilar, developed by BioImmunity LLC (搜索) — a company majority-owned by the Rossium Group (搜索) — representing the first copy of a monoclonal antibody produced in Belarus through a full manufacturing cycle. The biosimilar dossier is now undergoing pre-registration review by Russia's Health Ministry, the Russian investment holding company's press service confirmed. If successfully registered, the drug will become the second copy of an anti-interleukin-1 beta (搜索) antibody for treating severe orphan diseases in the Russian market.
The development effort was a tripartite collaboration between Russia's Federal Medical-Biological Agency, Russian biotech company Orfan-Bio (搜索), and Belarusian firm BioImmunity. The registration package is built on analytical test results alongside data from Phase I and Phase III clinical trials that directly compared the biosimilar with Novartis's original drug, Ilaris.
Clinical Trial Results Demonstrate Equivalence
The Phase I trial (ORP-001-1/PRIMA-1), completed in 2024, enrolled 80 healthy volunteers and demonstrated equivalence in pharmacokinetics, safety, and immunogenicity between the biosimilar and the original canakinumab product. Building on these findings, the Phase III trial (ORP-001-2/PRIMA-2) enrolled 112 patients with severe recurrent gouty arthritis (搜索) across more than 20 rheumatology centers in Russia. The pivotal study confirmed therapeutic equivalence, with most patients seeing their gout attack resolve within the first three days of treatment.
Switching Data Support Safety Profile
Twenty-four weeks of follow-up data confirmed the preventive effect of canakinumab in severe gout. Only isolated patients experienced recurrent attacks during the first three months of observation. Notably, after the third month, there were no reports of inefficacy, formation of anti-drug antibodies, or toxicity in patients who had previously been treated with Ilaris, indicating that switching from the original biologic to the biosimilar is safe.
Market Context and Indications
Canakinumab is included on Russia's list of vital and essential drugs and is procured for the Circle of Good foundation, underscoring its importance in the national healthcare system. The first canakinumab biosimilar in Russia was registered by domestic company Generium (搜索) under the trade name Limiris (搜索), which is produced through a full-cycle process in Russia. Both biosimilars target indications including Still's disease (搜索), juvenile arthritis (搜索), autoinflammatory conditions, and gouty arthritis (搜索).