The importance of World Health Organization international reference standards in the product life cycle of biosimilars

Technological advances in analytics, as well as scientific and regulatory knowledge and experience gained from biosimilar development/approvals over the last decade, enabled the World Health Organization (WHO) in 2022 to revise its guidelines on the evaluation of biosimilars. Among the revisions, th...

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Veröffentlicht in:	Annals of the New York Academy of Sciences 2024-10, Vol.1540 (1), p.225-234
Hauptverfasser:	Kang, Hye‐Na, Wadhwa, Meenu, Knezevic, Ivana, Burns, Chris, Griffiths, Elwyn
Format:	Artikel
Sprache:	eng
Schlagworte:	access Biological activity biosimilar Biosimilar Pharmaceuticals - standards Drug Approval - methods Humans international reference standards Life cycles Product life cycle Quality management Reference Standards regulation WHO World Health Organization
Online-Zugang:	Volltext
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