What are Biologics?

Pursuant to Clause 10, Article 2 of the Law on Pharmacy 2016, it is stipulated that:

Biological product (also known as biological drug) is a drug produced by technology or biological processes from substances or mixtures of high molecular weight substances of biological origin, including derivatives of human blood and plasma.

Biological products do not include antibiotics, low molecular weight biological substances that can be isolated into pure substances, and in vitro diagnostic biological products.

And based on Clauses 11 and 12 of this Article:

Reference biological product (also known as reference biological drug) is a biological product authorized for circulation in Vietnam on the basis of having complete data on quality, safety, and efficacy.

Similar biological product (also known as similar biological drug) is a biological product that is similar in quality, safety, and efficacy to a reference biological drug.

Respectfully!