Interchangeability for Biologics is a Legal Distinction in the USA, Not a Clinical One.
BioDrugs
; 36(4): 431-436, 2022 Jul.
Article
in English
| MEDLINE | ID: covidwho-1930606
ABSTRACT
Biologics are increasingly vital medicines that significantly reduce morbidity as well as mortality, yet access continues to be an issue even in apparently wealthy countries, such as the USA. While patient access is expected to improve with the introduction of biosimilars, misperceptions in a significant part based on terminology continue to make a sustained contribution by biosimilars difficult. Patients are and will continue to suffer needlessly if biosimilars continue to be impugned. Consequently, it is increasingly urgent that semantics are clarified, and in particular, the implication that interchangeable biologics are better biosimilars dismissed. This paper distinguishes between the real differences between biologics that matter clinically to patients and discusses the actual meaning of a US Food and Drug Administration designation of interchangeability for a biosimilar product. This will help highlight where there is need for further Food and Drug Administration education and which stakeholders likely need that education the most.
Full text:
Available
Collection:
International databases
Database:
MEDLINE
Main subject:
Biosimilar Pharmaceuticals
Type of study:
Prognostic study
Limits:
Humans
Country/Region as subject:
North America
Language:
English
Journal:
BioDrugs
Journal subject:
Allergy and Immunology
/
Genetics, Medical
/
Therapeutics
/
Drug Therapy
Year:
2022
Document Type:
Article
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