Biosimilar
Biosimilar
Biosimilar (pronunciation: /ˌbaɪoʊˈsɪmɪlər/) is a term used in the field of biotechnology to describe a biological product that is highly similar to and has no clinically meaningful differences from an existing FDA-approved reference product.
Etymology
The term "biosimilar" is derived from the words "biological" and "similar", indicating its nature as a near-identical copy of a biological product.
Definition
A biosimilar is a biological product that is approved based on showing that it is highly similar to an FDA-approved biological product, known as a reference product, and has no clinically meaningful differences in terms of safety and effectiveness from the reference product. Only minor differences in clinically inactive components are allowable in biosimilar products.
Related Terms
- Biologic Drug: A product that is produced from living organisms or contain components of living organisms. Biologics include recombinant proteins, tissues, genes, allergens, cells, blood components, blood, and vaccines. Biologic drugs are used for treating numerous disease and health conditions.
- Reference Product: A single biological product, already approved by the FDA against which a proposed biosimilar product is compared.
- Monoclonal Antibody: A type of protein made in the laboratory that can bind to substances in the body, including cancer cells. They play a significant role in biosimilar development.
- Pharmacovigilance: The science and activities relating to the detection, assessment, understanding and prevention of adverse effects or any other drug-related problem.
See Also
References
- FDA. (2017). Biosimilar and Interchangeable Products. Retrieved from https://www.fda.gov/drugs/biosimilars/biosimilar-and-interchangeable-products
External links
- Medical encyclopedia article on Biosimilar
- Wikipedia's article - Biosimilar
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