Biosimilar - CISMeF

Preferred Label : Biosimilar;

NCIt definition : A biological product that is highly similar in structure and function to, and has no clinically meaningful differences from, an FDA-approved reference product.;

Alternative definition : CDISC-GLOSS: A biological product that is highly similar to the reference product notwithstanding minor differences in clinically inactive components. This requires that there are no clinically meaningful differences between the biological product and the reference product in terms of the safety, purity, and potency of the product (see section 351(i)(2) of the PHS Act). [after FDA, Guidance for Industry: Quality Considerations in Demonstrating Biosimilarity of a Therapeutic Protein Product to a Reference Product];

NCI Metathesaurus CUI : CL935697;

Details

Origin ID

C156644;

UMLS CUI

C4045974;

Currated CISMeF NLP mapping
- Biosimilars [MeSH concept]
Semantic type(s)
- Pharmacologic Substance [UMLS semantic type]
Validated automatic mappings to NTBT
- biosimilar pharmaceuticals [MeSH Descriptor]
concept_is_in_subset
- CDISC Glossary Terminology [NCIt concept]
- Clinical Data Interchange Standards Consortium Terminology [NCIt concept]

Keyword's position in hierarchy(ies) :

Main resources

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