Belarus’s Health Ministry has approved the first canakinumab biosimilar, developed by BioImmunity LLC (majority owned by the Rossium Group). This is 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 told GxP News. If successfully registered, the drug will become the second copy of an anti‑interleukin‑1 beta antibody for treating severe orphan diseases.
The drug was developed in collaboration between Russia’s Federal Medical‑Biological Agency, Russian biotech Orfan‑Bio and Belarusian company BioImmunity. The registration is based on analytical test results and data from Phase I and Phase III clinical trials directly comparing the biosimilar with Novartis’s original drug Ilaris.
The Phase I trial (ORP‑001‑1/PRIMA‑1), completed in 2024 with 80 healthy volunteers, demonstrated equivalence in pharmacokinetics, safety and immunogenicity between the biosimilar and the original. The Phase III trial (ORP‑001‑2/PRIMA‑2), involving 112 patients with severe recurrent gouty arthritis from more than 20 rheumatology centres in Russia, confirmed therapeutic equivalence – most patients saw their gout attack resolved within the first three days.
Twenty‑four weeks of follow‑up confirmed the preventive effect of canakinumab in severe gout: only isolated patients experienced recurrent attacks in the first three months. After the third month, there were no reports of inefficacy, formation of anti‑drug antibodies or toxicity in patients previously treated with Ilaris, indicating that switching from the original to the biosimilar is safe.
Canakinumab is on Russia’s list of vital and essential drugs and is purchased for the Circle of Good foundation. The first canakinumab biosimilar in Russia was registered by domestic company Generium under the trade name Limiris. The drug is intended for Still’s disease, juvenile arthritis, autoinflammatory conditions and gouty arthritis. Limiris is produced in Russia through a full‑cycle process.
