바이오인

출처 : 미국 의회 조사국(Congressional Research Service)

바이오의약품 및 바이오시밀러 : 배경 및 주요 이슈

Biologics and Biosimilars: Background and Key Issues

Summary

A biological product, or biologic, is a preparation, such as a drug or a vaccine, that is made from living organisms. Compared with conventional chemical drugs, biologics are relatively large and complex molecules. They may be composed of proteins (and/or their constituent amino acids), carbohydrates (such as sugars), nucleic acids (such as DNA), or combinations of these substances. Biologics may also be cells or tissues used in transplantation.

A biosimilar, sometimes referred to as a follow-on biologic, is a therapeutic drug that is similar but not structurally identical to the brand-name biologic made by a pharmaceutical or biotechnology company. In contrast to the relatively simple structure and manufacture of chemical drugs, biosimilars, with their more complex nature and method of manufacture, will not be identical to the brand-name product, but may instead be shown to be highly similar. The Food and Drug Administration (FDA) regulates both biologics and chemical drugs.

...................(계속)

☞ 자세한 내용은 내용바로가기 또는 첨부파일을 이용하시기 바랍니다.