Biosimilars in rare diseases: a focus on paroxysmal nocturnal hemoglobinuria.
Haematologica
; 108(5): 1232-1243, 2023 05 01.
Article
em En
| MEDLINE
| ID: mdl-36519328
ABSTRACT
Biologics, a class of medicines grown in and purified from genetically engineered cell cultures, have transformed the management of many cancers and rare diseases, such as paroxysmal nocturnal hemoglobinuria. As prescription drug spending has increased and exclusivity periods have expired, manufacturers have developed biosimilars-biologics that may be more affordable and highly similar to a licensed biological therapeutic, with no clinically meaningful differences in terms of safety or efficacy. With biosimilars gaining regulatory approval around the globe and broadening patient access to biologics, this review aims to help rare disease healthcare providers familiarize themselves with biosimilars, understand their development and regulatory approval process, and address practical considerations that may facilitate their use.
Texto completo:
1
Base de dados:
MEDLINE
Assunto principal:
Medicamentos Biossimilares
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Hemoglobinúria Paroxística
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Neoplasias
Limite:
Humans
Idioma:
En
Ano de publicação:
2023
Tipo de documento:
Article