Vietnam's Drug Administration has approved Pembroria, a Russian-manufactured pembrolizumab biosimilar, marking a significant expansion in cancer treatment options for Vietnamese patients. The approval was part of a broader licensing initiative that included 14 vaccines and biological products approved for circulation at the end of October.
Drug Specifications and Manufacturing
Pembroria is produced by Russia's Limited Liability "PK-137" and registered by a facility in the United Arab Emirates. The formulation contains 100 mg of pembrolizumab per 4 ml, presented as a concentrated solution for intravenous infusion with a 24-month shelf life from the date of manufacture.
The drug represents a monoclonal antibody developed based on the original reference medicine by U.S. pharmaceutical company MSD (Merck & Co.), which has been licensed globally since 2017 for cancer treatment.
Clinical Applications and Cancer Burden
Pembroria has received approval for treating a wide range of malignancies, including lung carcinoma, melanoma, colorectal cancer, cervical cancer, renal cell carcinoma, and breast cancer. Health authorities emphasized that the approval expands access to advanced immunotherapy treatments for Vietnamese patients.
The drug's introduction addresses a significant medical need in Vietnam, where cancer represents one of the most serious health challenges. In 2022, the country recorded 180,480 new cancer cases, with breast, liver, lung, and colorectal cancers being the most prevalent forms.
Healthcare Implementation and Costs
Professor Le Van Quang, director of K Hospital, a leading cancer facility in Hanoi, confirmed that the hospital will soon make Pembroria available for patient use. However, the treatment remains outside Vietnam's health insurance coverage system.
The cost structure presents a significant financial consideration for patients, with each vial priced at approximately VND18 million ($700). Treatment protocols typically require two vials per cycle, bringing the total cost per treatment cycle to around $1,400.
Regulatory Context and International Cooperation
The approval represents part of Vietnam's expanding pharmaceutical landscape, which currently includes 99 cancer drugs in circulation. The latest batch of approvals also encompasses vaccines and biological products for treating stroke, lupus, osteoporosis, skin diseases, rheumatoid arthritis, ankylosing spondylitis, blood disorders, and multiple sclerosis.
The drug's approval follows strategic discussions during a Vietnam-Russia health meeting in September, where Health Minister Dao Hong Lan and her Russian counterpart Mikhail Murashko explored expanding cooperation in cancer vaccine research and technology transfer. Russia announced its new cancer vaccine in early September, describing it as a potentially revolutionary breakthrough in oncology.
Minister Lan expressed Vietnam's readiness to deepen collaboration in accessing, sharing, and transferring cancer-related vaccine technologies, while also broadening joint research, production, and clinical trials within Vietnam. Both countries agreed to strengthen cooperation across multiple healthcare domains, including rare-disease drug manufacturing, biotechnology, medical training, traditional medicine, health tourism, digital healthcare, and artificial intelligence applications.
Treatment Integration
Modern cancer treatment protocols in Vietnam incorporate surgery, chemotherapy, radiotherapy, targeted therapy, and immunotherapy approaches. Next-generation medicines such as pembrolizumab play an important role in these comprehensive treatment strategies, offering patients access to cutting-edge immunotherapy options that can complement existing therapeutic modalities.
