Promoting domestic production of biological drugs: A strategic direction to reduce the financial burden of cancer treatment in Vietnam.

SKĐS – In recent years, biological drugs have become an important segment in the pharmaceutical industry. The strong development in this field not only opens new avenues for advanced treatment therapies but also promises breakthroughs in the treatment of complex diseases.

“Vietnam is gradually moving towards mastering the technology of producing biopharmaceuticals, opening up opportunities to help people access cancer and chronic disease treatments at more reasonable prices,” Deputy Minister of Health Do Xuan Tuyen emphasized this at a discussion program on the development of the biopharmaceutical industry organized by Edelman and Vinapharm, held on May 28 in Hanoi.

According to the Deputy Minister of Health, the Vietnamese pharmaceutical industry has made significant progress in recent years. Currently, the country has 242 drug manufacturing plants, of which 21 meet EU-GMP standards, producing more than 800 active ingredients belonging to 13 essential medicine groups of the WHO.

Biological drugs – still a large “gap” in the field.
The pharmaceutical industry development strategy until 2030, with a vision to 2045, is concretized in the amended Law on Pharmaceuticals recently passed by the National Assembly, setting a target of producing 80% of the necessary medicines domestically and 70% of the market value by 2030. Although the Vietnamese pharmaceutical industry is gradually asserting its role in the region, biotechnology drugs remain a nascent field. Currently, there is only one biotechnology drug manufacturing facility nationwide and two facilities in the research and development phase.

Biological products are mainly concentrated in a few vaccines produced using conventional technology; there are not many highly effective biological products used in the treatment of specialized, critical diseases or emerging epidemics. The research and development capacity of enterprises is still limited, failing to keep up with and apply modern biotechnology.

“Currently, Vietnam is only at the stage of coordinating late-stage clinical trials and cannot proactively research and develop from the very beginning. Meanwhile, other countries have established closed-loop, continuous production processes, significantly reducing costs by eliminating intermediate steps that do not add value. We are aiming to proactively produce biological drugs, especially those for treating chronic diseases such as cancer. This will give people the opportunity to access drugs more quickly and at the most affordable prices, reducing treatment costs for patients,” Deputy Minister Do Xuan Tuyen emphasized.

Biological drugs are seen as a “lifesaver” for complex and difficult-to-treat diseases.

Biological drugs are medical products containing active ingredients produced or extracted from biological sources, such as living cells or tissues. This group includes many forms such as vaccines, blood and blood products, allergens, somatic cells, gene therapy, and recombinant therapeutic proteins. With their ability to profoundly impact disease mechanisms, biological drugs are considered a “lifesaver” for complex and difficult-to-treat diseases, but they also present challenges for the healthcare system due to their high cost and stringent technological requirements.

Dr. Ta Manh Hung, Deputy Director of the Drug Administration Department, Ministry of Health, also believes that the shift from producing generic drugs to biological drugs will open up significant development opportunities for domestic businesses.

“If Vietnam can master the technology and participate in the global supply chain, it can absolutely become the center for biopharmaceutical production in Southeast Asia,” Mr. Hung hoped.

To realize this goal, the Drug Administration of Vietnam will advise the Ministry of Health to propose policies to attract investment, simplify procedures, protect intellectual property, and develop an ecosystem to support research and production.
Dr. Ta Manh Hung stated that, aiming for “self-reliance and export growth,” and to make Vietnam “a regional center for high-value pharmaceutical production,” Law No. 44/2024/QH15 amending and supplementing several articles of the Law on Pharmaceuticals, effective from July 1, 2025, includes a series of policies prioritizing the development of the pharmaceutical industry, such as: preferential mechanisms to streamline the time and procedures for granting marketing authorization for special drugs, such as new drugs, original branded drugs, rare drugs, vaccines, and high-tech drugs; regulations on the use of funds such as the National Technology Innovation Fund, the National Science and Technology Development Fund, and the High-Tech Venture Capital Fund to support activities related to research, development, clinical trials, and commercialization of drugs; and combining state budget investment with resources from social mobilization to develop the industry for producing vaccines, biological products, herbal medicines, and traditional medicines. Preferential policies in procurement include policies on price fixing and discounts for new drugs, original branded drugs, high-tech drugs, vaccines, and rare drugs with manufacturing technology transferred to Vietnam…

Therefore, the new direction in biopharmaceutical production in Vietnam not only has strategic significance for healthcare but also represents a step forward in ensuring pharmaceutical security and proactively responding to future epidemics. In the context of the amended Pharmaceutical Law coming into effect on July 1, 2025, the discussion focused in depth on the professional aspects of the biopharmaceutical value chain, from basic research and clinical trials to production and policy frameworks and legal regulations.

In the coming period, the pharmaceutical industry will focus on implementing the following directions to promote the development of biopharmaceutical technology in Vietnam: Continuing to improve the legal framework, supplementing investment incentive policies to strongly attract domestic and foreign organizations/individuals to invest in research, transfer, and application of biotechnology in drug production; effectively implementing the National Strategy for the Development of the Vietnamese Pharmaceutical Industry, the Program for the Development of the Pharmaceutical and Medicinal Plant Industry, and the Program for Ensuring the Supply of Vaccines.

Notably, the pharmaceutical industry will develop concentrated industrial zones, prioritizing the biopharmaceutical industrial zone in Thai Binh and the high-tech medical and pharmaceutical zone in Ho Chi Minh City; focus on ensuring the supply of medicines and pharmaceutical raw materials, especially for rare and limitedly supplied drugs; strengthen drug quality management, inspection, handling of violations, and planning a nationwide testing system; improve the drug price management mechanism to stabilize the pharmaceutical market; strengthen inspection and post-inspection to ensure people have access to quality, effective, and affordable medicines; promote international cooperation and boost the export of medicines and cosmetics; enhance training and capacity building for officials and experts; maintain NRA level 3 for vaccines and coordinate to expand NRA achievement to all medicines; and promote administrative reform, digital transformation, and the application of artificial intelligence in the pharmaceutical industry.

Source : https://suckhoedoisong.vn/