In this list, it is worth noting the drug Pembroria® (INN: pembrolizumab), manufactured by JSC “BIOCAD” (Russia), registered for circulation in Vietnam through a facility in the United Arab Emirates. The drug is prepared in the form of a concentrated solution for infusion, with a shelf life of 24 months from the date of manufacture.
Speaking more about this drug that is attracting attention, a representative of the Drug Administration of the Ministry of Health said that Pembroria is not a new drug, but a biosimilar product of the original drug pembrolizumab produced by MSD Pharmaceutical Company (USA), which has been licensed for circulation since 2017.
The drug is licensed in Vietnam with a requirement that businesses periodically update the progress of clinical research to monitor phase III immunogenicity every 3 months, to supplement data on safety and compliance with risk management regulations.
The representative of the Drug Administration explained that monitoring immunogenicity in the post-licensing phase is supplementary safety data, not synonymous with the drug being in clinical trials. The process in Vietnam is even stricter than the regulations of the European Medicines Agency (EMA).
According to medical experts, Pembrolizumab is a monoclonal antibody belonging to the group of immune checkpoint inhibitors (PD-1/PD-L1 inhibitors). The mechanism is based on inhibiting the PD-1 receptor, a "switch" that helps cancer cells avoid attacks by the immune system.
When PD-1 is blocked, T cells are released to recognize and destroy cancer cells, marking a turning point in cancer treatment by taking advantage of the patient's own immune system instead of relying solely on chemicals.
The drug is indicated for many types of cancer, including non-small cell lung cancer, malignant melanoma, head and neck cancer, classical Hodgkin lymphoma, renal cell cancer, bladder, liver, stomach, esophageal, cervical, triple-negative breast cancer, cholangiocarcinoma and tumors with specific gene mutations such as MSI-H, high TMB or PD-L1 positive.
In practice, pembrolizumab is often used when the cancer has metastasized or the patient has not responded to traditional surgery, chemotherapy, or radiation therapy.
Since its FDA approval in 2014, pembrolizumab has demonstrated remarkable efficacy in prolonging survival and improving quality of life for patients with advanced cancer, particularly those with high PD-L1-expressing tumors. Some patients achieve complete remissions lasting for many years, which is rare with conventional treatment regimens.
In Vietnam, Pembroria is a biosimilar to Keytruda, helping to reduce treatment costs and increase access to advanced immunotherapy.
However, according to experts, it is not yet possible to evaluate the actual effectiveness of Pembroria on Vietnamese patients because the drug will only be available in our country from 2026. The quality of the drug depends on whether the research and production process is methodical and complies with international standards.
Because of its strong effect on the immune system, pembrolizumab can cause a serious immune reaction that affects the lungs, liver, kidneys, intestines, thyroid or adrenal glands, and can even be life-threatening if not detected promptly. Warning symptoms include cough, difficulty breathing, jaundice, severe diarrhea, fever, fatigue, and muscle and joint pain.
The drug is not recommended for pregnant or breastfeeding women. Mild to moderate side effects include nausea, loss of appetite, diarrhea, fatigue, hair loss, rash, itching, joint pain, and liver and kidney dysfunction.
According to GLOBOCAN 2022, Vietnam has about 180,480 new cases and 120,184 deaths from cancer, with common types including breast, liver, lung and colorectal cancer. The incidence and mortality rates increase year by year, putting great pressure on the health system in accessing modern treatments.
Currently, cancer treatment in Vietnam includes surgery, chemotherapy, radiotherapy, targeted drugs, immunotherapy and new generation drugs./.