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Definition of Biological products

[Sources: Regulation on Approval and Review of Biological Products]

Biological products refer to pharmaceuticals that is manufactured with raw materials or substances derived from human or other organisms and required special controls for protection of public health. Biological products include biologics, recombinant DNA product, cell culture-derived product, cell therapy product, gene therapy product, and others designated by the Minister of MFDS. (Article 2-9)

A biobetter product refers to a pharmaceutical that is designated by the Minister of MFDS and applied changed which is one of the following items A to D has improved safety-efficacy or usefulness (drug compliance and convenience, etc.) compared to the previously approved or advancement of the pharmaceutical technology.

A. Types of active ingredients or the mixing ratio

B. The route of administration

C. Dosage form

D. The addition of obviously different indications

(Article 2-9-2)

A biosimilar product refers to a biological product whose quality and nonclinical and clinical comparison of equivalence to a product already approved for manufacture, marketing, and importing is demonstrated. (Article 2-10)

Biologics refer to vaccines, plasma derived products and anti-toxin, etc. as pharmaceuticals containing a substance derived from or produced using living organisms and their potency and safety cannot be evaluated by only physical and chemical tests. (Article 2-11)

A recombinant DNA product (hereinafter referred to as the recombinant product) refers to a pharmaceutical that contains peptides or proteins as active ingredient produced through genetic manipulation technology. (Article 2-12)

A cell culture-derived product refers to a pharmaceutical that contains peptides or proteins as active ingredient produced through cell culture technology. (Article 2-13)

A cell therapy product refers to a pharmaceutical manufactured through physical, chemical, and/or biological manipulation, such as culture, proliferation, or selection of autologous, allogenic, or xenogeneic cells in vitro. However, it is exclude the case where a medical doctor conducts minimum manipulation which does not cause safety problems of autologous or allogenic cells in the course of the surgical operation or treatment at a medical institution (simple separation, washing, freezing, thawing, etc. to the extent of maintaining the biological properties). (Article 2-14)

A gene therapy product refers to genetic materials or a pharmaceutical that contains genetic materials that are administered into a human body for the purpose of disease treatment, etc. (Article 2-15)