9 more domestically produced drugs have proven bioequivalence

Mr. Nguyen Thanh Lam, Deputy Director of the Department of Drug Administration (Ministry of Health), has just signed a decision to announce the list of drugs with proven bioequivalence in the 10th phase of 2025, including 9 drugs produced by domestic pharmaceutical companies.

The above drugs belong to the group of antibiotics, drugs for treating dyslipidemia, treating high blood pressure, cardiovascular disease, and type 2 diabetes.

According to the regulations of the Ministry of Health , bioequivalence studies must be conducted at testing units that have been evaluated and recognized by competent authorities in the host country, and must be carried out in accordance with the principles of good clinical practice and good laboratory practice according to current regulations. The facility registering bioequivalent drugs must be responsible for providing full legally valid evidence that the research has been conducted.

Bioequivalence studies must be conducted at accredited and recognized testing facilities.

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According to a pharmaceutical expert, a bioequivalent drug (biosimilar) is a drug that is similar in quality, safety and clinical efficacy compared to a reference drug product or licensed original drug, and when used at the same dose under the same testing conditions, has equivalent therapeutic effects.

Bioequivalent drugs help increase access to treatment for patients, due to lower costs compared to licensed reference drugs.

Source: https://thanhnien.vn/them-9-thuoc-san-xuat-trong-nuoc-co-chung-minh-tuong-duong-sinh-hoc-18525090319531865.htm