Russia licensed the circulation of biological products containing the active ingredient olokizumab in Vietnam

The Russian biological product containing the active ingredient olokizumab has been granted a circulation registration certificate by the Ministry of Health in Vietnam, used according to the prescription and indication of a specialist.

According to Decision 145 of the Drug Administration, Ministry of Health, issued on March 17, the drug is in injection form, containing the active ingredient olokizumab, content of 64 mg/0.4 ml. The drug is produced by the Russian pharmaceutical enterprise R-Pharm. The issuance of circulation registration is based on records of quality, safety and effectiveness assessed by specialized management agencies according to regulations.

The registration process for new biotechnology drugs in Vietnam usually lasts 18-36 months, depending on documents and additional requirements. With this drug, the time to complete the registration procedure takes more than three years.

The production of biological products requires quality control at many stages, from input materials to finished products. Each production batch is tested against technical standards to ensure stability and uniformity.

Rheumatoid arthritis is a chronic autoimmune disease that occurs when the immune system mistakenly attacks healthy tissues, mainly in the joints. The disease can cause pain, swelling, stiffness and limited movement. If not controlled, prolonged inflammation can damage the joints.

Olokizumab is a monoclonal antibody that affects interleukin-6 (IL-6), a cytokine involved in the inflammatory response and progression of rheumatoid arthritis. The biologic was evaluated in the phase III CREDO clinical trial program in adults with moderate to severe active rheumatoid arthritis, including an inadequate response group to some prior treatments. Research results are one of the data used to evaluate the effectiveness and safety of active ingredients.

According to the manufacturer, the drug does not eliminate the cause of the disease. This is a prescription biological product, patient selection, combination with other drugs and monitoring during treatment must be decided by a specialist.